ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2013-00087
- Event Type
- Injury
- Date Received
- April 17, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 21, 2013
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
ADDENDUM: RECEIVED IMAGES AND ALL PROCEDURAL INFORMATION RECEIVED WERE SENT TO AN INDEPENDENT INTERVENTIONAL NEURO-RADIOLOGIST FOR REVIEW. THE REVIEWER REPORTED RECEIVING SIX JPG FILES ALONG WITH THE DESCRIPTION OF THE CASE. THE JPG IMAGES WERE APPARENTLY CAPTURED WITH A VIDEO CAMERA (CELL PHONE) FROM A COMPUTER SCREEN IN 640X478 PIXEL RESOLUTION WHICH IS ESSENTIALLY VGA QUALITY. CONSEQUENTLY, THE IMAGE QUALITY OF THE JPG FILES IS SUBSTANDARD. THE DESCRIPTION OF THE CASE LACKS DETAILS. IT IS KNOWN THAT THE DEVICE USED WAS A 28 MM ENTERPRISE VRD WITH A 12 MM DISTAL TIP DELIVERY WIRE. ALTHOUGH MICROCATHETER INFORMATION IS UNAVAILABLE, PER THE REVIEW, IT IS THOUGHT THAT IN THIS CASE THIS IS IRRELEVANT. THE INFORMATION GIVEN DESCRIBES THE FOLLOWING EVENTS: ¿WHEN THE PHYSICIAN RELEASED THE STENT, HE FOUND THE POSITION MARK OF DELIVERY WIRE DID NOT WITHDRAW WITH THE DELIVERY SYSTEM¿¿ THE REVIEW REPORTS THAT IN HIS OPINION, THE STENT RELEASE PROCESS DOES NOT REQUIRE ¿WITHDRAWAL¿ OF THE DELIVERY WIRE. ONLY AFTER THE STENT WAS RELEASED, WOULD THE DELIVERY WIRE BE REMOVED. THE REVIEWER ATTRIBUTES THIS DISCREPANCY TO WORDING BY THE REPORTER AND STATES THAT IT IS THOUGHT THAT THEY MEAN ¿AFTER THE PHYSICIAN RELEASED THE STENT¿¿. THE STENT WAS OBVIOUSLY RELEASED AND THEN THE OPERATOR ATTEMPTED TO PULL BACK THE DELIVERY WIRE. AS THE REVIEWER UNDERSTANDS FROM THE DESCRIPTION, THE PROXIMAL WIRE REMOVED EASILY BUT THE STENT DELIVERY PORTION DETACHED AND REMAINED THERE. THE SEPARATION OCCURRED AT THE CAROTID SIPHON. THE LOCATION IS A RATHER SENSITIVE ONE, BECAUSE ANY PULL OR PUSH APPLIES IN A 90-DEGREE ANGLE INSTEAD OF A STRAIGHT LINE. IF THE WIRE SYSTEM IS STILL PROTECTED BY A MICROCATHETER, THE CATHETER¿S STRUCTURE PROVIDES SUPPORT TO WHAT THE REVIEWER REFERS TO AS THE ¿JUNCTION POINT¿ WHICH IS DIAGRAMMATICALLY SHOWN AS THE SEPARATION POINT AROUND THE RETRACTION BUMP. IF THE CATHETER IS ALREADY PULLED BACK FULLY AND UNCOVERS NOT ONLY THIS ZONE BUT A LONGER PROXIMAL SEGMENT OF THE PUSHER WIRE AS WELL, THE REVIEWER REPORTS THE PUSH-PULL FORCE PROBABLY HAS A LIMITED RISK OF BREAKING AT THIS POINT BECAUSE OF THE FLIMSINESS OF THE PUSHER WIRE. HOWEVER, IF THE MICROCATHETER TIP IS LOCATED EXACTLY WHERE THIS AREA OF SEPARATION OCCURRED, AND PUSHING-PULLING FORCES ARE APPLIED, THE ADDED STRENGTH OF THE MICROCATHETER MAY FACILITATE BREAKING AT THAT ZONE. PER THE REVIEWER, THERE ARE TWO POSSIBILITIES DURING DELIVERY. THE OPERATOR EITHER ATTEMPTED TO RE-SHEATH THE STENT FOR SOME REASON OR THE STENT WAS RELEASED STRAIGHT, COMPLETELY, WITHOUT A RE-SHEATHING ATTEMPT. ALTHOUGH THE DESCRIPTION DOESN¿T TALK ABOUT SUCH RE-SHEATHING ATTEMPT, THE REVIEWER EVALUATED THE ANATOMY FOR POSSIBLE REASONS OF RE-SHEATHING, BASED ON THE AVAILABLE IMAGES. THE REVIEW CAME TO A CONCLUSION THAT THE POSITION OF THE ENTERPRISE VRD IN THE PATIENT¿S PARTICULAR ANATOMY IS IDEAL. THE 28 MM STENT DISTALLY ENDS IN THE LEFT MCA; PROXIMALLY IT ENDS IN THE PROJECTION OF THE ANTERIOR CLINOID PROCESS. THE ANEURYSM IS LOCATED AT THE ORIGIN OF THE LEFT POSTERIOR COMMUNICATING ARTERY, AND THE ANEURYSM NECK IS COVERED BY THE MIDDLE 1/3 OF THE DEVICE. THEREFORE, THE REVIEWER DOESN¿T SEE ANY REASON FOR RE-SHEATHING. ASSUMING THAT NO SUCH RE-SHEATHING ATTEMPT OCCURRED, THE EVENT MUST HAVE HAPPENED AFTER FINISHED AND COMPLETE DEPLOYMENT OF THE STENT. THERE ARE NO IMAGES AVAILABLE SHOWING THE ACTUAL EVENT, ALL IMAGES RECEIVED SHOW THE END RESULT OF THE WIRE BREAK. ONE IMAGE SHOWS THE MIDDLE MARKER BEING POSITIONED WITHIN THE STENT. THE PROXIMAL END (WHERE THE SYSTEM BROKE, WHICH IS DELINEATED BY THE REVIEWER ON A DIAGRAPH WHICH ENCIRCLES THE RETRACTION BUMP) IS JUST DISTAL TO THE CAROTID SIPHON, AS PREVIOUSLY MENTIONED. PER THE REVIEWER IF IT IS TRUE IN THE OPERATOR¿S DESCRIPTION THAT HE/SHE JUST SIMPLY PULLED THE DELIVERY WIRE WITHOUT THE NEED OF USING EXCESSIVE FORCE, AND THE WIRE SEPARATED, THEN THE REVIEWER¿S CONCLUSION IS THAT THERE MUST HAVE BEEN SOME SORT OF MECHANICAL DEFECT OF THE WIRE THAT PREDISPOSED IT FOR SEPARATION. IF HOWEVER THE REPORT FAILS TO MENTION SOME VIGOROUS PUSHING/PULLING OF THE DELIVERY SYSTEM, ESPECIALLY DURING A TIME WHEN THE CATHETER TIP WAS LOCATED AT THE PROXIMAL END OF THE STENT, THE REVIEWER REPORTS SEEING A POSSIBILITY OF MECHANICAL FAILURE OF THE WIRE DUE TO EXCESSIVE FORCE APPLIED TO THE WIRE/CATHETER COMBINATION IN AN ANGLE THAT EVENTUALLY MAY HAVE RESULTED IN A FOCAL STRESS AND SUBSEQUENT SEPARATION OF THE WIRE AT EXACTLY THE POINT WHERE THE SEPARATION HAS OCCURRED. THE REVIEWER REPORTS THAT UNFORTUNATELY, WITHOUT BETTER DESCRIPTION OF THE CASE AND WITHOUT FURTHER IMAGES SHOWING SUBSEQUENT STEPS OF THE MANIPULATION WITH THE ENTERPRISE VRD THE REVIEWER REPORTS THAT HIS OPINION IS HIGHLY SPECULATIVE. PLEASE NOTE THAT THIS NEW REVIEW OF IMAGES DOES NOT CHANGE ANY CODES IN THIS FILE. THIS IS JUST TO REPORT THE REVIEW OF IMAGES TO MEET REPORTING TIMELINE. UPDATED COMPLAINT CONCLUSION: IT WAS REPORTED THAT WHEN THE PHYSICIAN RELEASED THE STENT IT WAS FOUND THAT THE POSITION MARK OF THE DELIVERY WIRE OF THE ENTERPRISE VRD SYSTEM (ENC452812/10146439) DID NOT WITHDRAW WITH THE DELIVERY SYSTEM UNDER X-RAY. WITH CHECKING, THE SECTION WITH THE POSITION MARKER ON THE DELIVERY WIRE WAS BROKEN AND REMAINED IN THE BODY OF THE PATIENT. ADDITIONAL INFORMATION REPORTED THE SEPARATION OCCURRED DURING WITHDRAWAL FROM THE PATIENT. THERE WAS NO RESISTANCE DURING WITHDRAWAL. THE DELIVERY WIRE WAS NOT RESHAPED PRIOR TO USE AND THERE WAS NO RESISTANCE/FRICTION DURING INTRODUCTION OF THE ENTERPRISE THROUGH THE UNKNOWN MICROCATHETER. THE DELIVERY WIRE DID NOT PROLAPSE/GET ENTRAPPED BY THE STENT AS THE STENT WAS DEPLOYED. INTERACTION WITH THE STENT OR ANY OTHER DEVICE DID NOT APPEAR TO HAVE CONTRIBUTED TO THE SEPARATION. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE. THE DELIVERY WIRE WAS NOT LEFT IN PLACE DURING THE COILING AND THEN WITHDRAWN THROUGH THE DEPLOYED STENT WITHOUT FIRST ADVANCING THE MC THROUGH THE STENT. AFTER THE STENT WAS DEPLOYED THE MC WAS ADVANCED FORWARD THROUGH THE DEPLOYED STENT PRIOR TO WITHDRAWING THE DELIVERY WIRE THROUGH THE MC. NO ATTEMPT WAS MADE TO RETRIEVE THE DISTAL END FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿FINE¿ WITH NO CHANGE IN NEUROLOGICAL STATUS AND NO EFFECT OF BLOOD FLOW DUE TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE AND WITH FOLLOW-UP INVESTIGATION REGARDING THE REPORT THAT THE DISTAL END OF THE DELIVERY WIRE WOULD BE RETURNED, IT WAS REPORTED THAT THE DEVICE HAS NOT BEEN ABLE TO BE OBTAINED FOR ANALYSIS. RECEIVED IMAGES AND ALL PROCEDURAL INFORMATION RECEIVED WERE SENT TO AN INDEPENDENT INTERVENTIONAL NEURO-RADIOLOGIST FOR REVIEW. THE REVIEWER REPORTED RECEIVING SIX JPG FILES ALONG WITH THE DESCRIPTION OF THE CASE. THE JPG IMAGES WERE APPARENTLY CAPTURED WITH A VIDEO CAMERA (CELL PHONE?) FROM A COMPUTER SCREEN IN 640X478 PIXEL RESOLUTION WHICH IS ESSENTIALLY VGA QUALITY. CONSEQUENTLY, THE IMAGE QUALITY OF THE JPG FILES IS SUBSTANDARD. THE DESCRIPTION OF THE CASE LACKS DETAILS. IT IS KNOWN THAT THE DEVICE USED WAS A 28 MM ENTERPRISE VRD WITH A 12 MM DISTAL TIP DELIVERY WIRE. ALTHOUGH MICROCATHETER INFORMATION IS UNAVAILABLE, PER THE REVIEW, IT IS THOUGHT THAT IN THIS CASE THIS IS IRRELEVANT. THE INFORMATION GIVEN DESCRIBES THE FOLLOWING EVENTS: ¿WHEN THE PHYSICIAN RELEASED THE STENT, HE FOUND THE POSITION MARK OF DELIVERY WIRE DID NOT WITHDRAW WITH THE DELIVERY SYSTEM¿¿ THE REVIEW REPORTS THAT IN HIS OPINION, THE STENT RELEASE PROCESS DOES NOT REQUIRE ¿WITHDRAWAL¿ OF THE DELIVERY WIRE. ONLY AFTER THE STENT WAS RELEASED, WOULD THE DELIVERY WIRE BE REMOVED. THE REVIEWER ATTRIBUTES THIS DISCREPANCY TO WORDING BY THE REPORTER AND STATES THAT IT IS THOUGHT THAT THEY MEAN ¿AFTER THE PHYSICIAN RELEASED THE STENT¿¿. THE STENT WAS OBVIOUSLY RELEASED AND THEN THE OPERATOR ATTEMPTED TO PULL BACK THE DELIVERY WIRE. AS THE REVIEWER UNDERSTANDS FROM THE DESCRIPTION, THE PROXIMAL WIRE REMOVED EASILY BUT THE STENT DELIVERY PORTION DETACHED AND REMAINED THERE. THE SEPARATION OCCURRED AT THE CAROTID SIPHON. THE LOCATION IS A RATHER SENSITIVE ONE, BECAUSE ANY PULL OR PUSH APPLIES IN A 90-DEGREE ANGLE INSTEAD OF A STRAIGHT LINE. IF THE WIRE SYSTEM IS STILL PROTECTED BY A MICROCATHETER, THE CATHETER¿S STRUCTURE PROVIDES SUPPORT TO WHAT THE REVIEWER REFERS TO AS THE ¿JUNCTION POINT¿ WHICH IS DIAGRAMMATICALLY SHOWN AS THE SEPARATION POINT AROUND THE RETRACTION BUMP. IF THE CATHETER IS ALREADY PULLED BACK FULLY AND UNCOVERS NOT ONLY THIS ZONE BUT A LONGER PROXIMAL SEGMENT OF THE PUSHER WIRE AS WELL, THE REVIEWER REPORTS THE PUSH-PULL FORCE PROBABLY HAS A LIMITED RISK OF BREAKING AT THIS POINT BECAUSE OF THE FLIMSINESS OF THE PUSHER WIRE. HOWEVER, IF THE MICROCATHETER TIP IS LOCATED EXACTLY WHERE THIS AREA OF SEPARATION OCCURRED, AND PUSHING-PULLING FORCES ARE APPLIED, THE ADDED STRENGTH OF THE MICROCATHETER MAY FACILITATE BREAKING AT THAT ZONE. PER THE REVIEWER, THERE ARE TWO POSSIBILITIES DURING DELIVERY. THE OPERATOR EITHER ATTEMPTED TO RE-SHEATH THE STENT FOR SOME REASON OR THE STENT WAS RELEASED STRAIGHT, COMPLETELY, WITHOUT A RE-SHEATHING ATTEMPT. ALTHOUGH THE DESCRIPTION DOESN¿T TALK ABOUT SUCH RE-SHEATHING ATTEMPT, THE REVIEWER EVALUATED THE ANATOMY FOR POSSIBLE REASONS OF RE-SHEATHING, BASED ON THE AVAILABLE IMAGES. THE REVIEW CAME TO A CONCLUSION THAT THE POSITION OF THE ENTERPRISE VRD IN THE PATIENT¿S PARTICULAR ANATOMY IS IDEAL. THE 28 MM STENT DISTALLY ENDS IN THE LEFT MCA; PROXIMALLY IT ENDS IN THE PROJECTION OF THE ANTERIOR CLINOID PROCESS. THE ANEURYSM IS LOCATED AT THE ORIGIN OF THE LEFT POSTERIOR COMMUNICATING ARTERY, AND THE ANEURYSM NECK IS COVERED BY THE MIDDLE 1/3 OF THE DEVICE. THEREFORE, THE REVIEWER DOESN¿T SEE ANY REASON FOR RE-SHEATHING. ASSUMING THAT NO SUCH RE-SHEATHING ATTEMPT OCCURRED, THE EVENT MUST HAVE HAPPENED AFTER FINISHED AND COMPLETE DEPLOYMENT OF THE STENT. THERE ARE NO IMAGES AVAILABLE SHOWING THE ACTUAL EVENT, ALL IMAGES RECEIVED SHOW THE END RESULT OF THE WIRE BREAK. ONE IMAGE SHOWS THE MIDDLE MARKER BEING POSITIONED WITHIN THE STENT. THE PROXIMAL END (WHERE THE SYSTEM BROKE, WHICH IS DELINEATED BY THE REVIEWER ON A DIAGRAPH WHICH ENCIRCLES THE RETRACTION BUMP) IS JUST DISTAL TO THE CAROTID SIPHON, AS PREVIOUSLY MENTIONED. PER THE REVIEWER IF IT IS TRUE IN THE OPERATOR¿S DESCRIPTION THAT HE/SHE JUST SIMPLY PULLED THE DELIVERY WIRE WITHOUT THE NEED OF USING EXCESSIVE FORCE, AND THE WIRE SEPARATED, THEN THE REVIEWER¿S CONCLUSION IS THAT THERE MUST HAVE BEEN SOME SORT OF MECHANICAL DEFECT OF THE WIRE THAT PREDISPOSED IT FOR SEPARATION. IF HOWEVER THE REPORT FAILS TO MENTION SOME VIGOROUS PUSHING/PULLING OF THE DELIVERY SYSTEM, ESPECIALLY DURING A TIME WHEN THE CATHETER TIP WAS LOCATED AT THE PROXIMAL END OF THE STENT, THE REVIEWER REPORTS SEEING A POSSIBILITY OF MECHANICAL FAILURE OF THE WIRE DUE TO EXCESSIVE FORCE APPLIED TO THE WIRE/CATHETER COMBINATION IN AN ANGLE THAT EVENTUALLY MAY HAVE RESULTED IN A FOCAL STRESS AND SUBSEQUENT SEPARATION OF THE WIRE AT EXACTLY THE POINT WHERE THE SEPARATION HAS OCCURRED. THE REVIEWER REPORTS THAT UNFORTUNATELY, WITHOUT BETTER DESCRIPTION OF THE CASE AND WITHOUT FURTHER IMAGES SHOWING SUBSEQUENT STEPS OF THE MANIPULATION WITH THE ENTERPRISE VRD THE REVIEWER REPORTS THAT HIS OPINION IS HIGHLY SPECULATIVE. THE ENTERPRISE DELIVERY WIRE IS GROUND OF A SINGLE PIECE CORE WIRE WITH NO ¿JUNCTION POINTS¿. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10146439. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. BASED ON THE AVAILABLE PROCEDURAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED DELIVERY WIRE SEPARATION DURING WITHDRAWAL. THE INSTRUCTIONS FOR USE OUTLINES THAT PRIOR TO REMOVING THE DELIVERY WIRE, POSITION THE MICROCATHETER DISTAL TO THE STENT TO MAINTAIN ACCESS THROUGH THE STENT THEN REMOVE AND DISCARD THE DELIVERY SYSTEM. IT WARNS THAT IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. NO CONCLUSION CAN BE MADE REGARDING ROOT CAUSE OR POSSIBLE FACTORS CONTRIBUTING TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. FURTHER FOLLOW-UP WITH THE AFFILIATE CONFIRMED THAT THE PRODUCT DEVICE WILL BE RETURNED FOR ANALYSIS AND THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
CORRECTION: PLEASE NOTE THAT THE ALERT DATE OF PREVIOUSLY SUBMITTED FOLLOW-UP# 2 WAS REPORTED AS (B)(6) 2013 IN ERROR. THE CORRECT ALERT DATE SHOULD BE (B)(6) 2013 AS THE REVIEW NOTE WAS DATED ON (B)(6) 2013 BY THE REVIEWER.
IT WAS REPORTED THAT WHEN THE PHYSICIAN RELEASED THE STENT IT WAS FOUND THAT THE POSITION MARK OF THE DELIVERY WIRE OF THE ENTERPRISE VRD SYSTEM (ENC452812/10146439) DID NOT WITHDRAW WITH THE DELIVERY SYSTEM UNDER X-RAY. WITH CHECKING, THE SECTION WITH THE POSITION MARKER ON THE DELIVERY WIRE WAS BROKEN AND REMAINED IN THE BODY OF THE PATIENT. ADDITIONAL INFORMATION REPORTED THE SEPARATION OCCURRED DURING WITHDRAWAL FROM THE PATIENT. THERE WAS NO RESISTANCE DURING WITHDRAWAL. THE DELIVERY WIRE WAS NOT RESHAPED PRIOR TO USE AND THERE WAS NO RESISTANCE/FRICTION DURING INTRODUCTION OF THE ENTERPRISE THROUGH THE UNKNOWN MICROCATHETER. THE DELIVERY WIRE DID NOT PROLAPSE/GET ENTRAPPED BY THE STENT AS THE STENT WAS DEPLOYED. INTERACTION WITH THE STENT OR ANY OTHER DEVICE DID NOT APPEAR TO HAVE CONTRIBUTED TO THE SEPARATION. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE. THE DELIVERY WIRE WAS NOT LEFT IN PLACE DURING THE COILING AND THEN WITHDRAWN THROUGH THE DEPLOYED STENT WITHOUT FIRST ADVANCING THE MC THROUGH THE STENT. AFTER THE STENT WAS DEPLOYED THE MC WAS ADVANCED FORWARD THROUGH THE DEPLOYED STENT PRIOR TO WITHDRAWING THE DELIVERY WIRE THROUGH THE MC. NO ATTEMPT WAS MADE TO RETRIEVE THE DISTAL END FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿FINE¿ WITH NO CHANGE IN NEUROLOGICAL STATUS AND NO EFFECT OF BLOOD FLOW DUE TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE AND WITH FOLLOW-UP INVESTIGATION REGARDING THE REPORT THAT THE DISTAL END OF THE DELIVERY WIRE WOULD BE RETURNED, IT WAS REPORTED THAT THE DEVICE HAS NOT BEEN ABLE TO BE OBTAINED FOR ANALYSIS. (B)(4) REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10146439. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. BASED ON THE AVAILABLE PROCEDURAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED DELIVERY WIRE SEPARATION DURING WITHDRAWAL. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
UPDATED WITH ANALYSIS OF RETURNED DEVICE. IT WAS REPORTED THAT WHEN THE PHYSICIAN RELEASED THE STENT IT WAS FOUND THAT THE POSITION MARK OF THE DELIVERY WIRE OF THE ENTERPRISE VRD SYSTEM (ENC452812/10146439) DID NOT WITHDRAW WITH THE DELIVERY SYSTEM UNDER X-RAY. WITH CHECKING, THE SECTION WITH THE POSITION MARKER ON THE DELIVERY WIRE WAS BROKEN AND REMAINED IN THE BODY OF THE PATIENT. ADDITIONAL INFORMATION REPORTED THE SEPARATION OCCURRED DURING WITHDRAWAL FROM THE PATIENT. THERE WAS NO RESISTANCE DURING WITHDRAWAL. THE DELIVERY WIRE WAS NOT RESHAPED PRIOR TO USE AND THERE WAS NO RESISTANCE/FRICTION DURING INTRODUCTION OF THE ENTERPRISE THROUGH THE UNKNOWN MICROCATHETER. THE DELIVERY WIRE DID NOT PROLAPSE/GET ENTRAPPED BY THE STENT AS THE STENT WAS DEPLOYED. INTERACTION WITH THE STENT OR ANY OTHER DEVICE DID NOT APPEAR TO HAVE CONTRIBUTED TO THE SEPARATION. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE. THE DELIVERY WIRE WAS NOT LEFT IN PLACE DURING THE COILING AND THEN WITHDRAWN THROUGH THE DEPLOYED STENT WITHOUT FIRST ADVANCING THE MC THROUGH THE STENT. AFTER THE STENT WAS DEPLOYED THE MC WAS ADVANCED FORWARD THROUGH THE DEPLOYED STENT PRIOR TO WITHDRAWING THE DELIVERY WIRE THROUGH THE MC. NO ATTEMPT WAS MADE TO RETRIEVE THE DISTAL END FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿FINE¿ WITH NO CHANGE IN NEUROLOGICAL STATUS AND NO EFFECT OF BLOOD FLOW DUE TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. WITH ADDITIONAL FOLLOW-UP IT WAS REPORTED THAT THE DEVICE WAS NOT BEEN ABLE TO BE OBTAINED FOR ANALYSIS; HOWEVER, IT HAS NOW BEEN RETURNED. RECEIVED IMAGES AND ALL PROCEDURAL INFORMATION RECEIVED WERE SENT TO AN INDEPENDENT INTERVENTIONAL NEURO-RADIOLOGIST FOR REVIEW. THE REVIEWER REPORTED RECEIVING SIX JPG FILES ALONG WITH THE DESCRIPTION OF THE CASE. THE JPG IMAGES WERE APPARENTLY CAPTURED WITH A VIDEO CAMERA (CELL PHONE?) FROM A COMPUTER SCREEN IN 640X478 PIXEL RESOLUTION WHICH IS ESSENTIALLY VGA QUALITY. CONSEQUENTLY, THE IMAGE QUALITY OF THE JPG FILES IS SUBSTANDARD. THE DESCRIPTION OF THE CASE LACKS DETAILS. IT IS KNOWN THAT THE DEVICE USED WAS A 28 MM ENTERPRISE VRD WITH A 12 MM DISTAL TIP DELIVERY WIRE. ALTHOUGH MICROCATHETER INFORMATION IS UNAVAILABLE, PER THE REVIEW, IT IS THOUGHT THAT IN THIS CASE THIS IS IRRELEVANT. THE INFORMATION GIVEN DESCRIBES THE FOLLOWING EVENTS: ¿WHEN THE PHYSICIAN RELEASED THE STENT, HE FOUND THE POSITION MARK OF DELIVERY WIRE DID NOT WITHDRAW WITH THE DELIVERY SYSTEM¿¿ THE REVIEW REPORTS THAT IN HIS OPINION, THE STENT RELEASE PROCESS DOES NOT REQUIRE ¿WITHDRAWAL¿ OF THE DELIVERY WIRE. ONLY AFTER THE STENT WAS RELEASED, WOULD THE DELIVERY WIRE BE REMOVED. THE REVIEWER ATTRIBUTES THIS DISCREPANCY TO WORDING BY THE REPORTER AND STATES THAT IT IS THOUGHT THAT THEY MEAN ¿AFTER THE PHYSICIAN RELEASED THE STENT¿¿. THE STENT WAS OBVIOUSLY RELEASED AND THEN THE OPERATOR ATTEMPTED TO PULL BACK THE DELIVERY WIRE. AS THE REVIEWER UNDERSTANDS FROM THE DESCRIPTION, THE PROXIMAL WIRE REMOVED EASILY BUT THE STENT DELIVERY PORTION DETACHED AND REMAINED THERE. THE SEPARATION OCCURRED AT THE CAROTID SIPHON. THE LOCATION IS A RATHER SENSITIVE ONE, BECAUSE ANY PULL OR PUSH APPLIES IN A 90-DEGREE ANGLE INSTEAD OF A STRAIGHT LINE. IF THE WIRE SYSTEM IS STILL PROTECTED BY A MICROCATHETER, THE CATHETER¿S STRUCTURE PROVIDES SUPPORT TO WHAT THE REVIEWER REFERS TO AS THE ¿JUNCTION POINT¿ WHICH IS DIAGRAMMATICALLY SHOWN AS THE SEPARATION POINT AROUND THE RETRACTION BUMP. IF THE CATHETER IS ALREADY PULLED BACK FULLY AND UNCOVERS NOT ONLY THIS ZONE BUT A LONGER PROXIMAL SEGMENT OF THE PUSHER WIRE AS WELL, THE REVIEWER REPORTS THE PUSH-PULL FORCE PROBABLY HAS A LIMITED RISK OF BREAKING AT THIS POINT BECAUSE OF THE FLIMSINESS OF THE PUSHER WIRE. HOWEVER, IF THE MICROCATHETER TIP IS LOCATED EXACTLY WHERE THIS AREA OF SEPARATION OCCURRED, AND PUSHING-PULLING FORCES ARE APPLIED, THE ADDED STRENGTH OF THE MICROCATHETER MAY FACILITATE BREAKING AT THAT ZONE. PER THE REVIEWER, THERE ARE TWO POSSIBILITIES DURING DELIVERY. THE OPERATOR EITHER ATTEMPTED TO RE-SHEATH THE STENT FOR SOME REASON OR THE STENT WAS RELEASED STRAIGHT, COMPLETELY, WITHOUT A RE-SHEATHING ATTEMPT. ALTHOUGH THE DESCRIPTION DOESN¿T TALK ABOUT SUCH RE-SHEATHING ATTEMPT, THE REVIEWER EVALUATED THE ANATOMY FOR POSSIBLE REASONS OF RE-SHEATHING, BASED ON THE AVAILABLE IMAGES. THE REVIEW CAME TO A CONCLUSION THAT THE POSITION OF THE ENTERPRISE VRD IN THE PATIENT¿S PARTICULAR ANATOMY IS IDEAL. THE 28 MM STENT DISTALLY ENDS IN THE LEFT MCA; PROXIMALLY IT ENDS IN THE PROJECTION OF THE ANTERIOR CLINOID PROCESS. THE ANEURYSM IS LOCATED AT THE ORIGIN OF THE LEFT POSTERIOR COMMUNICATING ARTERY, AND THE ANEURYSM NECK IS COVERED BY THE MIDDLE 1/3 OF THE DEVICE. THEREFORE, THE REVIEWER DOESN¿T SEE ANY REASON FOR RE-SHEATHING. ASSUMING THAT NO SUCH RE-SHEATHING ATTEMPT OCCURRED, THE EVENT MUST HAVE HAPPENED AFTER FINISHED AND COMPLETE DEPLOYMENT OF THE STENT. THERE ARE NO IMAGES AVAILABLE SHOWING THE ACTUAL EVENT, ALL IMAGES RECEIVED SHOW THE END RESULT OF THE WIRE BREAK. ONE IMAGE SHOWS THE MIDDLE MARKER BEING POSITIONED WITHIN THE STENT. THE PROXIMAL END (WHERE THE SYSTEM BROKE, WHICH IS DELINEATED BY THE REVIEWER ON A DIAGRAPH WHICH ENCIRCLES THE RETRACTION BUMP) IS JUST DISTAL TO THE CAROTID SIPHON, AS PREVIOUSLY MENTIONED. PER THE REVIEWER IF IT IS TRUE IN THE OPERATOR¿S DESCRIPTION THAT HE/SHE JUST SIMPLY PULLED THE DELIVERY WIRE WITHOUT THE NEED OF USING EXCESSIVE FORCE, AND THE WIRE SEPARATED, THEN THE REVIEWER¿S CONCLUSION IS THAT THERE MUST HAVE BEEN SOME SORT OF MECHANICAL DEFECT OF THE WIRE THAT PREDISPOSED IT FOR SEPARATION. IF HOWEVER THE REPORT FAILS TO MENTION SOME VIGOROUS PUSHING/PULLING OF THE DELIVERY SYSTEM, ESPECIALLY DURING A TIME WHEN THE CATHETER TIP WAS LOCATED AT THE PROXIMAL END OF THE STENT, THE REVIEWER REPORTS SEEING A POSSIBILITY OF MECHANICAL FAILURE OF THE WIRE DUE TO EXCESSIVE FORCE APPLIED TO THE WIRE/CATHETER COMBINATION IN AN ANGLE THAT EVENTUALLY MAY HAVE RESULTED IN A FOCAL STRESS AND SUBSEQUENT SEPARATION OF THE WIRE AT EXACTLY THE POINT WHERE THE SEPARATION HAS OCCURRED. THE REVIEWER REPORTS THAT UNFORTUNATELY, WITHOUT BETTER DESCRIPTION OF THE CASE AND WITHOUT FURTHER IMAGES SHOWING SUBSEQUENT STEPS OF THE MANIPULATION WITH THE ENTERPRISE VRD THE REVIEWER REPORTS THAT HIS OPINION IS HIGHLY SPECULATIVE. THE ENTERPRISE DELIVERY WIRE IS GROUND OF A SINGLE PIECE CORE WIRE WITH NO ¿JUNCTION POINTS¿. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10146439. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. A NON-STERILE ENTERPRISE DELIVERY WIRE AND PROWLER SELECT PLUS MICROCATHETER (MC) WERE RECEIVED COILED INSIDE OF A PLASTIC BAG. THE ENTERPRISE WAS RECEIVED INSIDE OF THE MC. THE MC HUB WAS INSPECTED AND NO VISUAL DAMAGE WAS FOUND. THE ENTERPRISE INTRODUCER TUBE WAS NOT RECEIVED. THE MC WAS INSPECTED AND NO DAMAGES WERE OBSERVED. SOME WAVES WERE NOTED ON THE DEVICE; HOWEVER THESE APPEAR TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. IT IS NOTED THAT IT WAS REPORTED THAT THERE WAS NO RESISTANCE BETWEEN THE ENTERPRISE AND MC DURING PROCEDURAL USE. AFTER REMOVAL OF THE ENTERPRISE FROM THE MC A FRACTURE ON THE DELIVERY WIRE AT 180CM FROM THE PROXIMAL END IS NOTED. THE ENTERPRISE STENT AND THE DISTAL END OF THE DELIVERY WIRE WERE NOT RETURNED; AS REPORTED THEY REMAIN IN THE PATIENT. SEM ANALYSIS OF THE ENTERPRISE DELIVERY WIRE SHOWED THAT THE CORE WIRE FRACTURE SURFACES PRESENTED EVIDENCE OF DUCTILE DIMPLES. STRETCHING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS; HOWEVER THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO CHARACTERISTICS TYPICAL OF THIS FAILURE MODE WERE OBSERVED. THE REPORTED DELIVERY WIRE SEPARATION WAS CONFIRMED. BASED ON THE AVAILABLE PROCEDURAL INFORMATION AND LIMITED PROVIDED IMAGES, NO CONCLUSION CAN BE MADE. HOWEVER, BASED ON THE ANALYSIS WITH THE SEM RESULTS SHOWING THAT THE CORE WIRE FRACTURE SURFACES PRESENTED EVIDENCE OF DUCTILE DIMPLES, STRETCHING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. THE RETURNED DEVICE DID NOT PRESENT WITH ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY CONTRIBUTING TO THE REPORTED EVENT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS A RELATIONSHIP OF THE EVENT TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED; HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THEREFORE NO ACTIONS WILL BE TAKEN AT THIS TIME.
PER (B)(4) -(B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10146439. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4) AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4)'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT IS EXPECTED TO BE RETURNED AND THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING THE PROCEDURE, IT WAS REPORTED THAT THE POSITION MARK OF DELIVERY WIRE DID NOT WITHDRAW WITH THE DELIVERY SYSTEM UNDER X-RAY WHEN THE PHYSICIAN RELEASED THE STENT. THUS THE PHYSICIAN CHECKED WITH THIS AND FOUND THAT THE SECTION OF POSITION MARK ON DELIVERY SYSTEM WAS BROKEN AND REMAINED IN THE BODY OF PATIENT. THE ENTERPRISE DELIVERY WIRE WAS NOT RESHAPED PRIOR TO THE USE. THERE WAS NO RESISTANCE DURING INTRODUCTION OF ENTERPRISE THROUGH MC. THE DELIVERY WIRE DID NOT PROLAPSE OR GET ENTRAPPED BY THE STENT AS IT WAS BEING DEPLOYED. THE DELIVERY WIRE SEPARATION OCCURRED DURING WITHDRAWAL; HOWEVER, THERE WAS NO RESISTANCE DURING WITHDRAWAL. IT WAS REPORTED AFTER THE STENT WAS DEPLOYED, THE MICROCATHETER WAS ADVANCED FORWARD THROUGH THE DEPLOYED STENT PRIOR TO WITHDRAWING THE DELIVERY WIRE THROUGH THE MICROCATHETER. THE INTERACTION WITH THE STENT OR ANY OTHER DEVICES DID NOT APPEAR TO HAVE CONTRIBUTED TO THIS EVENT. THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE WIRE. NO TORQUING OF THE WIRE AGAINST RESISTANCE WAS NOTED. PATIENT'S CONDITION IS FINE. THERE WERE NO CHANGES IN THE PATIENT'S NEURO STATUS DUE TO THE EVENT. NO EFFECT ON BLOOD FLOW NOTED DUE TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164319 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 10146439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |