ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00096
- Event Type
- Injury
- Date Received
- February 28, 2018
- Date of Event
- February 2, 2018
- Report Date
- March 30, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384900
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #P100022/S014. (B)(4). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1410844 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A .014¿ DIAMETER, SPARTACORE WIRE GUIDE. THE DEVICE WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE. THE TARGET SITE WAS MODERATELY CALCIFIED. PRE-DILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE CUSTOMER CONFIRMED THAN AN AIF INTERVENTION REFERS TO AORTA ILIAC FEMORAL PROCEDURE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 22ND FEBRUARY 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE HANDLE WAS RETURNED DISASSEMBLED. 10MM OF THE STENT WAS OBSERVED EXITING THE DISTAL END OF THE STENT RETRACTION SHEATH (SRS), AND A FURTHER 95MM WAS STILL LOADED INSIDE THE SRS. A KINK WAS OBSERVED IN THE STABILITY SHEATH (SS), WHERE THE SS WOULD BE COVERED BY THE STRAIN RELIEF. CRINKLES WERE FOUND ON THE SRS. THERE WAS EVIDENCE THAT THE STENT WAS FRACTURED, WITH APPROXIMATELY 15MM OF THE STENT NOT RETURNED WITH THE DEVICE. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. THE DEVICE WAS FLUSHED WITH NO RESISTANCE. A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE, AND RESISTANCE WAS ENCOUNTERED AT THE KINK IN THE SS. CONGEALED BLOOD WAS OBSERVED EXITING THE DELIVERY SYSTEM. THE SS WAS CUT DURING THE LAB, AND DAMAGE WAS FOUND ON THE PROXIMAL INNER AT A LOCATION CORRESPONDING TO THE KINK IN THE SS, AT THE FIRST LASER CUT. THERE WAS NO DAMAGE NOTED ON THE DISTAL WHITE TIP. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IS THE COMPLAINT CONFIRMED? YES. STENT FRACTURE FROM THE INABILITY TO COMPLETE STENT DEPLOYMENT IS CONFIRMED. THE TWISTING AND/OR KINKING OF THE DELIVERY SYSTEM JUST PROXIMAL TO THE HANDLE SEPARATED THE RETRACTION RIBBON FROM THE RETRACTION SHEATH. THIS LIKELY HAPPENED OUTSIDE THE PATIENT. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: NONE. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: NONE. OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: THE DIMINISHED SUPPORT PROVIDED BY A .014 WIRE RATHER A .035 WIRE WOULD HAVE INCREASED THE PROBABILITY OF KINKING. BECAUSE THE SUSPECTED ANTEGRADE ACCESS WOULD HAVE RESULTED IN A SIGNIFICANT LENGTH OF DELIVERY SYSTEM OUTSIDE THE PATIENT, THE RISK OF INADVERTENTLY KINKING OR TWISTING THE DELIVERY SYSTEM WAS ENHANCED. STENT DEPLOYMENT WAS POSSIBLE HAD THE OPERATOR EXPOSED THE RETRACTION SHEATH MORE THAN 9CM DISTAL TO THE HANDLE BY CUTTING THROUGH THE SUPPORT SHEATH. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE. FINDINGS: 1. A SINGLE IMAGE IS PROVIDED ALONG WITH MULTIPLE IMAGES AND A SHORT NARRATIVE FROM THE DEVICE LAB EVALUATION. 2. THE SINGLE IMAGE DEMONSTRATES AN APPROXIMATELY 15MM LONG ZILVER PTX FRAGMENT IN THE RIGHT COMMON FEMORAL ARTERY (CFA). A SHEATH TIP IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA) WAS INJECTED WITH CONTRAST, FILLING THE DISTAL RIGHT EXTERNAL ILIAC ARTERY (EIA), CFA, PROXIMAL PROFUNDA FEMORAL ARTERY AND PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE SHEATH HAD MOST LIKELY BEEN INTRODUCED THROUGH THE LEFT CFA AND LESS LIKELY THROUGH A BRACHIAL ARTERY APPROACH. WIRE ACCESS HAD BEEN LOST. THE DISTAL EIA WAS DEEPLY DISSECTED, POSSIBLY RUPTURED AND LIKELY NEARLY, IF NOT COMPLETELY, OCCLUDED. SUBTRACTION ARTIFACT REVEALED A LARGE PSEUDOANEURYSM PARTIALLY FILLING WITH CONTRAST THROUGH A LARGE CFA DEFECT AT THE STENT FRAGMENT. 3. APPROXIMATELY 27MM OF STENT HAD BEEN DEPLOYED WITH 15MM REMAINING IN THE PATIENT. 4. AT 27MM OF DEPLOYMENT, THE RETRACTION RIBBON AND RETRACTION SHEATH BOND WOULD HAVE BEEN LOCATED AT THE DELIVERY SYSTEM KINK AND TWIST. 5. THE EVENT WAS SIGNIFICANTLY MORE COMPLICATED THAT THE COMPLAINT REPORT NARRATIVE INDICATES. A LARGE HOLE IN THE RIGHT CFA SUPPLYING A LARGE PSEUDOANEURYSM AND THE RIGHT EIA INJURY SUGGEST THAT THE ACCESS WAS ANTEGRADE THROUGH THE RIGHT CFA WITH THE STENT BREAKING OFF AS THE SHEATH AND DELIVERY SYSTEM WERE PULLED OUT THE ACCESS. THIS WOULD ALSO EXPLAIN WHY WIRE ACCESS WAS LOST ACROSS THE STENT FRAGMENT. MAINTAINING WIRE ACCESS ACROSS THE FRAGMENT WAS OF PARAMOUNT IMPORTANCE AS IT WOULD INSURE ADDITIONAL STENT DEPLOYMENT THROUGH THE FRAGMENT LUMEN RATHER THAN POSSIBLY THROUGH ITS INTERSTICES. CONSEQUENTLY, HAD THE PROCEDURE BEEN ORIGINALLY PERFORMED THROUGH THE EIA, A WIRE THROUGH THE STENT ON THE PROVIDED IMAGE WOULD HAVE BEEN ANTICIPATED. IMPRESSION: 1. STENT FRACTURE FROM THE INABILITY TO COMPLETE STENT DEPLOYMENT IS CONFIRMED. THE TWISTING AND/OR KINKING OF THE DELIVERY SYSTEM JUST PROXIMAL TO THE HANDLE SEPARATED THE RETRACTION RIBBON FROM THE RETRACTION SHEATH. THIS MOST LIKELY HAPPENED OUTSIDE THE PATIENT. THE DIMINISHED SUPPORT PROVIDED BY A .014 WIRE RATHER A .035 WIRE WOULD HAVE INCREASED THE PROBABILITY OF KINKING. BECAUSE THE SUSPECTED ANTEGRADE ACCESS WOULD HAVE RESULTED IN A SIGNIFICANT LENGTH OF DELIVERY SYSTEM OUTSIDE THE PATIENT, THE RISK OF INADVERTENTLY KINKING OR TWISTING THE DELIVERY SYSTEM WAS ENHANCED. 2. STENT DEPLOYMENT WAS POSSIBLE HAD THE OPERATOR EXPOSED THE RETRACTION SHEATH MORE THAN 9CM DISTAL TO THE HANDLE BY CUTTING THROUGH THE SUPPORT SHEATH. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT AS THE DEVICE WAS ADVANCED THROUGH THE CALCIFIED ANATOMY. THE INSUFFICIENT SUPPORT COULD HAVE LED TO THE KINKS IN THE STABILITY SHEATH AND PROXIMAL INNER COMPONENTS. THE KINKS COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH, PREVENTING DEPLOYMENT AND CAUSING THE STENT FRACTURE AS THE DEVICE WAS WITHDRAWN. THE IMAGE REVIEW ALSO CONCLUDED THAT THE TWISTING AND/OR KINKING OF THE DELIVERY SYSTEM JUST PROXIMAL TO THE HANDLE COULD HAVE CAUSED OR CONTRIBUTED TO THE SEPARATION OF THE RETRACTION RIBBON FROM THE RETRACTION SHEATH. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT AS PER THE PRODUCT INSTRUCTION FOR USE: PRECAUTIONS: ¿A 0.035 INCH (0.89MM) DIAMETER WIRE GUIDE SHOULD BE USED DURING TRACKING, DEPLOYMENT AND REMOVAL IN ORDER TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM¿ A CAPA HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE THE STENT RETRACTION WIRE/STENT RETRACTION SHEATH JOINT SEPARATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THIS LOT NUMBER. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN ADDITIONAL STENT REQUIRED TO COVER THE BROKEN STENT COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS INITIAL MDR IS BEING SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT REQUIRED SURGICAL INTERVENTION. AS REPORTED TO CUSTOMER RELATIONS: " DURING AN AIF INTERVENTION PROCEDURE ON A MALE PATIENT THE ZILVER PTX 35 DRUG-ELUTING STENT (G38490) WAS USED. A 6X5 FR ANSEL SHEATH WAS ALSO USED. THE PHYSICIAN HAD BALLOON AND LASERED THE SFA. ADVANCED THE DEVICE INTO THE SFA AND DEPLOYED THE FIRST 20 MM AND IT WOULD NOT GO ANY FURTHER. THE PHYSICIAN WAS STILL TURNING THE THUMB WHEEL AND THE STENT WOULD NOT ADVANCE. PULLED BACK SLIGHTLY ON STENT AND TRIED THE THUMBWHEEL BUT ONLY ELONGATED THE STENT. THE PHYSICIAN TOOK THE HANDLE APART TO MANUALLY DEPLOY BY PULLING BACK ON THE WIRE BUT THE WIRE WAS ALREADY BROKE. WHILE REMOVING THE PART OF DEPLOYED STENT APPROXIMATELY 10 MM OF STENT BROKE OFF IN THE PATIENT OVER THE FEMORAL HEAD. THE PHYSICIAN REMOVED EVERYTHING ELSE OF THE DEVICE. THEN WENT IN WITH A 7X80 R35 LP BALLOON AND BALLOON THE STENT UP AGAINST THE WALL. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 3 FURTHER STENTS. ONE STENT WAS CONFIRMED TO BE COVERING THE 10 MM FRAGMENT OF STENT SECURELY. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED."
THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS WITH IMAGE REVIEW. INITIAL MDR SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT REQUIRED SURGICAL INTERVENTION. AS REPORTED TO CUSTOMER RELATIONS: "DURING AN AIF INTERVENTION PROCEDURE ON A MALE PATIENT THE ZILVER PTX 35 DRUG-ELUTING STENT (G38490) WAS USED. A 6X5 FR ANSEL SHEATH WAS ALSO USED. THE PHYSICIAN HAD BALLOON AND LASERED THE SFA. ADVANCED THE DEVICE INTO THE SFA AND DEPLOYED THE FIRST 20 MM AND IT WOULD NOT GO ANY FURTHER. THE PHYSICIAN WAS STILL TURNING THE THUMB WHEEL AND THE STENT WOULD NOT ADVANCE. PULLED BACK SLIGHTLY ON STENT AND TRIED THE THUMBWHEEL BUT ONLY ELONGATED THE STENT. THE PHYSICIAN TOOK THE HANDLE APART TO MANUALLY DEPLOY BY PULLING BACK ON THE WIRE BUT THE WIRE WAS ALREADY BROKE. WHILE REMOVING THE PART OF DEPLOYED STENT APPROXIMATELY 10MM OF STENT BROKE OFF IN THE PATIENT OVER THE FEMORAL HEAD. THE PHYSICIAN REMOVED EVERYTHING ELSE OF THE DEVICE. THEN WENT IN WITH A 7X80 R35 LP BALLOON AND BALLOON THE STENT UP AGAINST THE WALL. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 3 FURTHER STENTS. ONE STENT WAS CONFIRMED TO BE COVERING THE 10MM FRAGMENT OF STENT SECURELY. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED."
PMA/510(K) #P100022/S014. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PROBLEM STATEMENT "AS REPORTED TO CUSTOMER RELATIONS: " DURING AN AIF INTERVENTION PROCEDURE ON A MALE PATIENT THE ZILVER PTX 35 DRUG-ELUTING STENT (G38490) WAS USED. A 6X5 FR ANSEL SHEATH WAS ALSO USED. THE PHYSICIAN HAD BALLOON AND LASERED THE SFA. ADVANCED THE DEVICE INTO THE SFA AND DEPLOYED THE FIRST 20 MM AND IT WOULD NOT GO ANY FURTHER. THE PHYSICIAN WAS STILL TURNING THE THUMB WHEEL AND THE STENT WOULD NOT ADVANCE. PULLED BACK SLIGHTLY ON STENT AND TRIED THE THUMBWHEEL BUT ONLY ELONGATED THE STENT. THE PHYSICIAN TOOK THE HANDLE APART TO MANUALLY DEPLOY BY PULLING BACK ON THE WIRE BUT THE WIRE WAS ALREADY BROKE. WHILE REMOVING THE PART OF DEPLOYED STENT APPROXIMATELY 10MM OF STENT BROKE OFF IN THE PATIENT OVER THE FEMORAL HEAD. THE PHYSICIAN REMOVED EVERYTHING ELSE OF THE DEVICE. THEN WENT IN WITH A 7X80 R35 LP BALLOON AND BALLOON THE STENT UP AGAINST THE WALL. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 3 FURTHER STENTS. ONE STENT WAS CONFIRMED TO BE COVERING THE 10MM FRAGMENT OF STENT SECURELY. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED." DEVICE EVALUATION: THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1410844 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.014¿ DIAMETER, SPARTACORE WIRE GUIDE. THE DEVICE WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE. THE TARGET SITE WAS MODERATELY CALCIFIED. PRE-DILATION WAS CONDUCTED PRIOR TO THIS OCCURRENCE. THE CUSTOMER CONFIRMED THAN AN AIF INTERVENTION REFERS TO AORTA ILIAC FEMORAL PROCEDURE. IMAGES OF THE IMPLANTED STENT WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES HAVE BEEN REVIEWED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 22ND FEBRUARY 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE HANDLE WAS RETURNED DISASSEMBLED. 10MM OF THE STENT WAS OBSERVED EXITING THE DISTAL END OF THE STENT RETRACTION SHEATH (SRS), AND A FURTHER 95MM WAS STILL LOADED INSIDE THE SRS. A KINK WAS OBSERVED IN THE STABILITY SHEATH (SS), WHERE THE SS WOULD BE COVERED BY THE STRAIN RELIEF. CRINKLES WERE FOUND ON THE SRS. THERE WAS EVIDENCE THAT THE STENT WAS FRACTURED, WITH APPROXIMATELY 15MM OF THE STENT NOT RETURNED WITH THE DEVICE. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. THE DEVICE WAS FLUSHED WITH NO RESISTANCE. A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE, AND RESISTANCE WAS ENCOUNTERED AT THE KINK IN THE SS. CONGEALED BLOOD WAS OBSERVED EXITING THE DELIVERY SYSTEM. THE SS WAS CUT DURING THE LAB, AND DAMAGE WAS FOUND ON THE PROXIMAL INNER AT A LOCATION CORRESPONDING TO THE KINK IN THE SS, AT THE FIRST LASER CUT. THERE WAS NO DAMAGE NOTED ON THE DISTAL WHITE TIP. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT AS THE DEVICE WAS ADVANCED THROUGH THE CALCIFIED ANATOMY. THE INSUFFICIENT SUPPORT COULD HAVE LED TO THE KINKS IN THE STABILITY SHEATH AND PROXIMAL INNER COMPONENTS. THE KINKS COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH, PREVENTING DEPLOYMENT AND CAUSING THE STENT FRACTURE AS THE DEVICE WAS WITHDRAWN. HOWEVER, AS THE IMAGES HAVE NOT YET BEEN REVIEWED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT AS PER THE PRODUCT INSTRUCTION FOR USE: PRECAUTIONS: ¿A 0.035 INCH (0.89MM) DIAMETER WIRE GUIDE SHOULD BE USED DURING TRACKING, DEPLOYMENT AND REMOVAL IN ORDER TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM¿ A CAPA ((B)(4)) HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE THE STENT RETRACTION WIRE/STENT RETRACTION SHEATH JOINT SEPARATION. DOCUMENT REVIEW: A REVIEW OF INCOMING QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THIS LOT NUMBER. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN ADDITIONAL STENT REQUIRED TO COVER THE BROKEN STENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. INITIAL MDR SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT REQUIRED SURGICAL INTERVENTION. AS REPORTED TO CUSTOMER RELATIONS: " DURING AN AIF INTERVENTION PROCEDURE ON A MALE PATIENT THE ZILVER PTX 35 DRUG-ELUTING STENT (G38490) WAS USED. A 6X5 FR ANSEL SHEATH WAS ALSO USED. THE PHYSICIAN HAD BALLOON AND LASERED THE SFA. ADVANCED THE DEVICE INTO THE SFA AND DEPLOYED THE FIRST 20 MM AND IT WOULD NOT GO ANY FURTHER. THE PHYSICIAN WAS STILL TURNING THE THUMB WHEEL AND THE STENT WOULD NOT ADVANCE. PULLED BACK SLIGHTLY ON STENT AND TRIED THE THUMBWHEEL BUT ONLY ELONGATED THE STENT. THE PHYSICIAN TOOK THE HANDLE APART TO MANUALLY DEPLOY BY PULLING BACK ON THE WIRE BUT THE WIRE WAS ALREADY BROKE. WHILE REMOVING THE PART OF DEPLOYED STENT APPROXIMATELY 10MM OF STENT BROKE OFF IN THE PATIENT OVER THE FEMORAL HEAD. THE PHYSICIAN REMOVED EVERYTHING ELSE OF THE DEVICE. THEN WENT IN WITH A 7X80 R35 LP BALLOON AND BALLOON THE STENT UP AGAINST THE WALL. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 3 FURTHER STENTS. ONE STENT WAS CONFIRMED TO BE COVERING THE 10MM FRAGMENT OF STENT SECURELY. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146322 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38490 | 10827002384900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |