ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2017-00113
- Event Type
- Injury
- Date Received
- March 31, 2017
- Date of Event
- March 1, 2017
- Report Date
- April 27, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002352909
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
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. PMA/510(K) #P100022/S014. THE ZISV6-35-125-7.0-120-PTX DEVICE OF LOT C1286891 WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE SURGEON CANNOT REMEMBER IF THE STABILITY SHEATH WAS IN THE ACCESS SHEATH DURING DEPLOYMENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE WIRE GUIDE OR THE DELIVERY SYSTEM. NO RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT OF THE STENT. 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: FINDINGS: 1. IMPLANTATION ANGIOGRAPHY IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE INTENDED IMPLANTATION SITE WAS THE PROXIMAL SFA. A PTX STENT HAD JUST BEEN SUCCESSFULLY IMPLANTED IN THE DISTAL SFA. AFTER THE SECOND STENT COULD NOT BE DEPLOYED, ITS ENTIRE DELIVERY SYSTEM AS PULLED BACK IN AN ATTEMPT TO RECAPTURE THE STENT INSIDE THE ACCESS SHEATH. THIS SUCCEEDED IN RECAPTURING ALL BUT THE DISTAL MOST CENTIMETER OF THE STENT. 3. DURING THE RETRACTION, THE DELIVERY SHEATH TIP WAS FLUSH WITH THE DELIVERY SHEATH MARKER, INDICATING THAT THE DELIVERY SHEATH WAS FIXED INSIDE THE ACCESS SHEATH OR HELD IN PLACE OUTSIDE THE PATIENT. OTHERWISE THE DELIVERY SHEATH, WHICH HAD ALREADY BEEN PARTIALLY RETRACTED, WOULD HAVE MAINTAINED ITS SEPARATION WITH THE DELIVERY SYSTEM TIP. 4. THE ANTEGRADE ACCESS' SHORT PURCHASE CREATED A SITUATION WHERE THE OPERATOR COULD INADVERTENTLY GRAB THE RETRACTING PORTION OF THE DELIVERY SHEATH OUTSIDE THE PATIENT IN AN ATTEMPT TO STABILIZE THE SYSTEM. THE OPERATOR SHOULD HAVE BEEN ABLE TO SENSE THE TENSION BEING APPLIED BY THE WHEEL; HOWEVER, BECAUSE IT WAS A 125CM DELIVERY SYSTEM, IT MAY HAVE WELL BEEN AN ASSISTANT STABILIZING THE DELIVERY SYSTEM. IN THIS SCENARIO THE ASSISTANT AND OPERATOR MAY HAVE BEEN UNAWARE THAT EACH WAS COMPETING AGAINST THE OTHER. BECAUSE THE FIRST STENT DELIVERY SYSTEM WAS INSERTED DEEPER, ONLY THE IMMOBILE PORTION OF THE SHEATH WAS EXPOSED. A SIMILAR STABILIZATION MANEUVER WOULD HAVE GONE UNNOTICED AND PERHAPS CREATED A FALSE SENSE OF SAFETY. 5. DELIVERY SYSTEM RETRACTION DEPLOYED THE STENT WITHIN THE ACCESS SHEATH. 6. THE REMAINDER OF THE IMAGING DEMONSTRATES EVENTUAL STENT REMOVAL BY A SNARE PLACED FROM A LEFT UP AND OVER RETROGRADE ACCESS. ALL BUT A SMALL FRAGMENT OF THE STENT WAS REMOVED. THIS WAS SUCCESSFULLY TRAPPED BY A THIRD PTX STENT IMPLANTED THROUGH THE RETROGRADE ACCESS. 7. BECAUSE IT WAS AN ANTEGRADE ACCESS, THE ACCESS SITE ANGLE WAS STEEPER THAN USUAL. THE COMBINATION OF THE ACCESS SHEATH, THE .014 GUIDE WIRE AND ZILVER DELIVERY SYSTEM APPEARED TO CREATE A VERY GENTLE ACCESS ANGLE IN THE ANTERIOR/ POSTERIOR PROJECTION. HOWEVER WHEN VIEWED OBLIQUELY IT WAS QUITE ACUTE. THE CATHETER WAS ANGLED AT LEAST 87 DEGREES OVER A 15MM RADIUS. THE ACCESS SHEATH WAS KINKED AS IT EXITED THE SKIN. HOWEVER BECAUSE THIS WAS ONLY OBSERVED AFTER THE STENT HAD BEEN DEPLOYED IN THE ACCESS SHEATH, IT MAY HAVE OCCURRED AFTER THE DELIVERY SYSTEM FAILURE. IMPRESSION: 1. THE RETRACTING PORTION OF THE DELIVERY SHEATH WAS FIXED EITHER IN THE ACCESS SHEATH AND OR INADVERTENTLY MANUALLY HELD OUTSIDE THE PATIENT. THIS RESISTANCE CAUSED THE METAL RETRACTION RIBBON TO SEPARATE FROM THE RETRACTING PORTION OF THE SHEATH. SINCE A SIGNIFICANT AMOUNT OF FORCE IS REQUIRED TO SEPARATE THE RIBBON FROM THE SHEATH, A WEAK BOND BETWEEN THE RIBBON AND SHEATH WAS ALSO LIKELY. 2. THE ACUTE ACCESS ANGLE, USE OF A 0.014 WIRE IN A 0.035 WIRE DEVICE AND THE SHORT PURCHASE CREATED A SITUATION THAT WOULD HAVE INCREASED THE FRICTION BETWEEN THE RETRACTING PORTION OF THE DELIVERY SYSTEM AND THE ACCESS SHEATH. THE SHORT PURCHASE EXPOSED THE RETRACTING PORTION OF THE SHEATH TO INADVERTENT MANUAL FIXATION. 3. THE STENT LIKELY COULD HAVE BEEN SUCCESSFULLY DEPLOYED HAD THE OPERATOR DISASSEMBLED THE DELIVERY SYSTEM HANDLE AND RETRACTED THE SHEATH WHILE FIXING THE INNER CANNULA IN A MANNER SIMILAR TO THE ORIGINAL DEPLOYMENT HANDLE. 4. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED. THE ANTEGRADE ACCESS ANGLE WAS STEEP AND THE DELIVERY SYSTEM PURCHASE SHORT. 5. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. 6. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE SHEATH ACCESS ANGLE WAS INCREASED BY THE USE OF A 0.014 WIRE IN A 0.035 DEVICE. THIS INCREASED THE DELIVERY SYSTEM ACCESS SHEATH FRICTION. ALSO, THE RETRACTING PORTION OF THE DELIVERY SHEATH MAY HAVE BEEN INADVERTENTLY STABILIZED OUTSIDE THE PATIENT. 7. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE METAL RETRACTION RIBBON SEPARATED FROM THE RETRACTING SHEATH. THIS BOND LIKELY WAS WEAK. 8. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF A NON RECOMMENDED WIRE GUIDE, THE PATIENT ANATOMY AND THE USE OF THE DEVICE IN AN ANTEGRADE APPROACH. THE CUSTOMER REPORTED THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.014" WIRE GUIDE. THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. IN ADDITION, THE USE OF THE DEVICE IN AN ANTEGRADE APPROACH CREATED A STEEP ACCESS ANGLE AND MEANT THE DELIVERY SYSTEM PURCHASE WAS SHORT. THERE WAS ALSO A POSSIBILITY THAT THE DEVICE WAS FIXED INSIDE THE ACCESS SHEATH OR BEING HELD BY THE OPERATOR. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT. FROM THE IMAGE REVIEW, IT WAS SUGGESTED THAT THE METAL RETRACTION RIBBON (STENT RETRACTION WIRE) SEPARATED FROM THE STENT RETRACTION SHEATH, AND THIS MAY HAVE BEEN DUE TO A WEAK BOND. RESEARCH AND DEVELOPMENT (R&D) WERE CONTACTED TO REVIEW THE INFORMATION, BUT WERE UNABLE TO CONFIRM THAT THE BOND WAS WEAK, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. R&D STATED THAT THE WIRE GUIDE AND PATIENT ANATOMY WERE THE MOST LIKELY POSSIBLE CAUSES. HOWEVER, AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PACKAGING INSERT: "UNDER FLUOROSCOPY, ADVANCE THE DELIVERY SYSTEM OVER A 0.89-MM (0.035-INCH) GUIDE WIRE THROUGH THE SHEATH UNTIL THE DISTAL END STENT MARKER GOES BEYOND THE TARGET LESION." "TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM, INTRODUCE A 0.89MM (0.035 INCH) GUIDE WIRE THROUGH THE SHEATH ACROSS THE DISTAL SEGMENT OF THE TARGET LESION." PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. 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 LOT NUMBER C1286891. ACCORDING TO THE INITIAL REPORTER, THERE HAVE BEEN NO ADVERSE EVENTS REPORTED FOR THE PATIENT AS A RESULT OF THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
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. PMA/510(K) #P100022/S014. THE ZISV6-35-125-7.0-120-PTX DEVICE OF LOT C1286891 WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE SURGEON CANNOT REMEMBER IF THE STABILITY SHEATH WAS IN THE ACCESS SHEATH DURING DEPLOYMENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE WIRE GUIDE OR THE DELIVERY SYSTEM. NO RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT OF THE STENT. IMAGES OF THE PROCEDURE HAVE BEEN REQUESTED. THE INVESTIGATION WILL BE UPDATED IF THE IMAGES ARE PROVIDED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF A NON RECOMMENDED WIRE GUIDE. THE CUSTOMER REPORTED THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.014" WIRE GUIDE. THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT, AND CAUSED OR CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT. HOWEVER, AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PACKAGING INSERT: "UNDER FLUOROSCOPY, ADVANCE THE DELIVERY SYSTEM OVER A 0.89-MM (0.035-INCH) GUIDE WIRE THROUGH THE SHEATH UNTIL THE DISTAL END STENT MARKER GOES BEYOND THE TARGET LESION." "TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM, INTRODUCE A 0.89MM (0.035 INCH) GUIDE WIRE THROUGH THE SHEATH ACROSS THE DISTAL SEGMENT OF THE TARGET LESION." PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. 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 LOT NUMBER C1286891. ACCORDING TO THE INITIAL REPORTER, THERE HAVE BEEN NO ADVERSE EVENTS REPORTED FOR THE PATIENT AS A RESULT OF THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: THE DEVICE WAS USED ON A PATIENT WITHOUT ANATOMICAL ISSUES CONFIRMED BY CT PRIOR TO THE PROCEDURE. A SHEATH (6FR. 10CM BY MEDIKIT) WAS INSERTED FROM THE RIGHT FA. POBA WAS PERFORMED WITH A 5MM BALLOON AFTER ADVANCING A 0.014INCH WIRE GUIDE PAST THE STENOSED LESION. SINCE SEVERE DISSECTION OCCURRED, THE PHYSICIAN DECIDED TO PLACE ZILVER PTX STENTS. AFTER PLACING ONE 7MM-120CM (LOT UNKNOWN), HE ATTEMPTED TO PLACE ANOTHER STENT (= COMPLAINT DEVICE ZISV6-35-125-7.0-120-PTX/ C1286891) IN THE PROXIMAL SITE. HOWEVER, AFTER THE STENT PARTIALLY (APPROXIMATELY 7MM) DEPLOYED, THE THUMBWHEEL KEPT ROTATING WITHOUT WITHDRAWING THE OUTER SHEATH. THE PARTIALLY DEPLOYED STENT COULD NOT BE PULLED BACK INTO THE OUTER SHEATH, SO A CROSS-OVER SHEATH WAS INSERTED FROM THE CONTRALATERAL SIDE AND A SNARE DEVICE WAS ADVANCED THROUGH THE SHEATH TO RETREIVE THE PARTIALLY DEPLOYED SEGMENT BY BREAKING THE STENT. THE STENT WAS SEPARATED IN TWO PIECES (ONE SIDE PARTIALLY DEPLOYED AND ANOTHER SIDE UNDEPLOYED INSIDE THE SHEATH) AND THE PARTIALLY DEPLOYED SEGMENT COULD BE RETRIEVED WITH THE SNARE. AFTER REMOVING THE DELIVERY SYSTEM WITH THE UNDEPLOYED STENT INSIDE, ANOTHER PTX - 7.0MM-80MM WAS USED INSTEAD. THERE WAS NO STENT SEGMENT REMAINED INSIDE THE PATIENT AND THE 7.0MM-80MM STENT COULD BE PLACED SUCCESSFULLY TO COMPLETE THE PROCEDURE.
THE DEVICE WAS USED ON A PATIENT WITHOUT ANATOMICAL ISSUES CONFIRMED BY CT PRIOR TO THE PROCEDURE. A SHEATH (6FR. 10 CM BY (B)(6)) WAS INSERTED FROM THE RIGHT FA. POBA WAS PERFORMED WITH A 5 MM BALLOON AFTER ADVANCING A 0.014 INCH WIRE GUIDE PAST THE STENOSED LESION. SINCE SEVERE DISSECTION OCCURRED, THE PHYSICIAN DECIDED TO PLACE ZILVER PTX STENTS. AFTER PLACING ONE 7 MM-120 CM (LOT UNKNOWN), HE ATTEMPTED TO PLACE ANOTHER STENT (= COMPLAINT DEVICE ZISV6-35-125-7.0-120-PTX/ C1286891) IN THE PROXIMAL SITE. HOWEVER, AFTER THE STENT PARTIALLY (APPROXIMATELY 7 MM) DEPLOYED, THE THUMBWHEEL KEPT ROTATING WITHOUT WITHDRAWING THE OUTER SHEATH. THE PARTIALLY DEPLOYED STENT COULD NOT BE PULLED BACK INTO THE OUTER SHEATH, SO A CROSS-OVER SHEATH WAS INSERTED FROM THE CONTRALATERAL SIDE AND A SNARE DEVICE WAS ADVANCED THROUGH THE SHEATH TO RETRIEVE THE PARTIALLY DEPLOYED SEGMENT BY BREAKING THE STENT. THE STENT WAS SEPARATED IN TWO PIECES (ONE SIDE PARTIALLY DEPLOYED AND ANOTHER SIDE UNDEPLOYED INSIDE THE SHEATH) AND THE PARTIALLY DEPLOYED SEGMENT COULD BE RETRIEVED WITH THE SNARE. AFTER REMOVING THE DELIVERY SYSTEM WITH THE UNDEPLOYED STENT INSIDE, ANOTHER PTX - 7.0 MM-80 MM WAS USED INSTEAD. THERE WAS NO STENT SEGMENT REMAINED INSIDE THE PATIENT AND THE 7.0 MM-80 MM STENT COULD BE PLACED SUCCESSFULLY TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233658 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | 10827002352909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |