ZILVER 635 VASCULAR SELF-EXPANDING STENT

Report

Report Number: 3001845648-2018-00181
Event Type: Malfunction
Date Received: April 26, 2018
Date of Event: March 29, 2018
Report Date: August 9, 2018
Manufacturer: COOK IRELAND LTD
Product Code: NIO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 0

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)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. PROBLEM STATEMENT: "TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH." DEVICE EVALUATION: THE TWO ZIV6-35-125-8-80 STENTS OF LOT NUMBERS C1117723 AND C1260575 INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENT, AND WERE NOT AVAILABLE FOR EVALUATION. THE DEVICE DELIVERY SYSTEMS WERE RETURNED, 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 STENT WAS USED WITH A FEMORAL ENDARTERECTOMY IN THE EXTERNAL ILIAC ARTERIES (EIA) FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A POST DEPLOYMENT PTA WAS CONDUCTED, WHICH RESULTED IN EXTRAVASATION OF BLOOD FROM THE STENTED PORTION OF THE VESSEL. ANOTHER STENT WAS PLACED TO COVER THE AREA OF EXTRAVASATION. THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE IMPLANTED STENTS SHORTENING. THE PATIENT ULTIMATELY REQUIRED ADDITIONAL SURGERIES AND EVENTUALLY AMPUTATION OF THE LOWER LIMB. HOWEVER, ACCORDING TO THE DISTRICT MANAGER, THIS WAS LIKELY DUE TO PROGRESSION OF PERIPHERAL VASCULAR DISEASE, DISTAL TO THE FEMORAL ARTERIES. THE CUSTOMER STATED THAT BOTH STENTS WERE MEANT TO BE 80MM LONG. ONE OF THE IMPLANTED STENTS APPEARED TO BE HALF ITS SPECIFIED LENGTH. THE STENTS WERE MEASURED VISUALLY. 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? NO. IMPLANTATION OF A SHORT ZIV6 WAS NOT CONFIRMED . IMPLANTATION OF THE COMPLAINT ZIV6 TO HALF ITS DESIGN LENGTH IS CONFIRMED. THE SHORTENING WAS SECONDARY TO A CONCERTINATED STENT RATHER THAN AN INCORRECTLY PACKAGED STENT. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: THIS TYPE OF MAL-DEPLOYMENT HAS BEEN OBSERVED IN OTHER CASES WHERE STENTS ARE DEPLOYED WITH LIMITED DIAMETER OR NO PRE-IMPLANTATION ANGIOPLASTY IN STENOSES WITH SIMILAR CHARACTERISTICS. THESE CHARACTERISTICS INCLUDE MODERATE TO SEVERE OR WORSE STENOSES CONTAINING HEAVILY CALCIFIED IRREGULAR PLAQUE. RATHER THAN BEING ALLOWED TO EXPAND WITHOUT CONTACTING PLAQUE UNTIL RELATIVELY PARALLEL TO THE LUMEN, THE PLAQUE TURNS EACH STENT ROW PERPENDICULAR TO THE LUMEN. THIS CONTINUOUS SHORTENING OF THE DEPLOYING STENT EXTRACTS THE STENT FROM THE DEPLOYMENT SHEATH. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: NONE. OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: THE ORIGINAL STENT'S SEVERE CONSTRAINT AND BOTH STENTS' IMPROVEMENT AFTER ANGIOPLASTY INDICATE THAT ANGIOPLASTY PRIOR TO IMPLANTATION OF THE FIRST STENT WAS NOT PERFORMED. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE. FINDINGS: TWO ANGIOGRAPHIC IMAGES PHOTOGRAPHED OFF A MONITOR ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. THE FIRST IMAGE IS A MAGNIFIED, SUBTRACTED AP (ANTERIOR/ POSTERIOR PROJECTION) IMAGE OF THE RECENTLY DEPLOYED COMPLAINT ZIV6. THE ZIV6 HAD BEEN IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA) FROM A RIGHT COMMON FEMORAL ARTERY (CFA) ACCESS. THE SECOND IMAGE IS AN UNSUBTRACTED, SLIGHTLY LESS MAGNIFIED AP IMAGE TAKEN DURING ANGIOPLASTY OF THE SECOND ZIV6. ALTHOUGH EXACT CALIBRATION IS NOT POSSIBLE, THE POST IMPLANTATION ANGIOPLASTY BALLOON APPEARED TO BE AN 8MMX60MM BALLOON. THE FEMORAL HEAD WAS IMAGED ENOUGH TO ASCERTAIN ITS DIAMETER. A NORMAL FEMORAL HEAD DIAMETER IS 42MM. ONLY A 60CM LONG BALLOON MATCHED A NORMAL FEMORAL HEAD DIAMETER. THE BALLOON COULD NOT HAVE BEEN 80MM LONG; OTHERWISE, ITS DIAMETER WOULD HAVE MEASURED LARGER THAN THE 8MM DIAMETER ZIV6 AND THE FEMORAL HEAD WOULD HAVE MEASURED MUCH LARGER THAN THE LARGEST OF HUMANS. LIKEWISE, THE BALLOON DID NOT APPEAR 40MM LONG AND IF 40MM, THE FEMORAL HEAD WOULD HAVE BEEN MUCH SMALLER THAN THE SMALLEST OF HUMANS. ASSUMING A 60MM LONG BALLOON, THE FIRST ZIV6 WAS DEPLOYED IN A SEVERELY CALCIFIED, IRREGULAR, AND MODERATE TO SEVERELY NARROWED EIA. THE ZIV6 WAS CONCERTINAED TO 40MM AND CENTRALLY COMPRESSED TO 40MM. THE ZIV6'S ENDS WERE NARROWED TO 3MM AND SO DISTORTED FROM LUMEN IRREGULARITY THAT THEY WERE UNRECOGNIZABLE AS CIRCULAR ENDS. INSTEAD, THE END MARKERS WERE SEPARATED BY AS MUCH AS 7MM ALONG THE LENGTH OF THE ARTERY. THE SECOND ZIV6 WAS IMPLANTED INSIDE THE FIRST. ITS IMPLANTED LENGTH WAS 65MM. IT EXTENDED FROM THE PROXIMAL END OF THE FIRST ZIV6 TO 2.5CM BEYOND THE FIRST ZIV6'S DISTAL END. THE ANGIOPLASTY BALLOON EXTENDED FROM THE MID FIRST ZIV6 INFERIORLY TO THE EIA/ CFA JUNCTION. IT WAS FULLY EXPANDED EXCEPT EACH END WHERE IT WAS STILL 20% CONSTRAINED . FROM THE MID FIRST ZIV6 SUPERIORLY, ALTHOUGH SIGNIFICANTLY IMPROVED, BOTH STENTS WERE STILL CONSTRAINED OVER 30%. THE ORIGINAL STENT'S SEVERE CONSTRAINT AND BOTH STENTS' IMPROVEMENT AFTER ANGIOPLASTY INDICATE THAT ANGIOPLASTY PRIOR TO IMPLANTATION OF THE FIRST STENT WAS NOT PERFORMED. IMPRESSION: IMPLANTATION OF A SHORT STENT WAS NOT CONFIRMED. IMPLANTATION OF THE COMPLAINT STENT TO HALF ITS DESIGN LENGTH IS CONFIRMED. THE SHORTENING WAS SECONDARY TO A CONCERTINAED STENT RATHER THAN AN INCORRECTLY PACKAGED STENT. THIS TYPE OF MALDEPLOYMENT HAS BEEN OBSERVED IN OTHER CASES WHERE STENTS ARE DEPLOYED WITH LIMITED DIAMETER OR NO PRE-IMPLANTATION ANGIOPLASTY IN STENOSES WITH SIMILAR CHARACTERISTICS. THESE CHARACTERISTICS INCLUDE MODERATE TO SEVERE OR WORSE STENOSES CONTAINING HEAVILY CALCIFIED IRREGULAR PLAQUE. RATHER THAN BEING ALLOWED TO EXPAND WITHOUT CONTACTING PLAQUE UNTIL RELATIVELY PARALLEL TO THE LUMEN, THE PLAQUE TURNS EACH STENT ROW PERPENDICULAR TO THE LUMEN. THIS CONTINUOUS SHORTENING OF THE DEPLOYING STENT EXTRACTS THE STENT FROM THE DEPLOYMENT SHEATH. ALTHOUGH NOT A SUBJECT OF THE COMPLAINT, THE SECOND STENT ALSO DEPLOYED SHORTER THAN ITS DESIGN LENGTH. THIS LIKELY OCCURRED THROUGH THE SAME MECHANISM EXCEPT THAT IT WAS EXTRACTED BY THE CONCERTINAED FIRST STENT RATHER THAN PLAQUE. THE TWO DEVICES RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14TH JUNE 2018. ON EVALUATION OF THE FIRST RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT. THE DISTANCE BETWEEN THE PROXIMAL END OF THE DISTAL WHITE TIP AND THE PUSHER RING WAS 94MM, WHICH WAS WITHIN SPECIFICATION. THE DEVICE WAS FLUSHED BOTH PORTS, AND A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE WITHOUT RESISTANCE. NO TACTILE DAMAGE WAS OBSERVED ON THE FLEXOR. ON EVALUATION OF THE SECOND RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT. THE DISTANCE BETWEEN THE PROXIMAL END OF THE DISTAL WHITE TIP AND THE PUSHER RING WAS 91MM, WHICH WAS OUTSIDE SPECIFICATION, LIKELY DUE TO COMPRESSION OF THE INNER PEEK CATHETER DURING ADVANCEMENT. THE DEVICE WAS FLUSHED BOTH PORTS WITHOUT ISSUES. A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE AND ENCOUNTERED RESISTANCE DUE TO CONGEALED BLOOD IN THE DEVICE LUMEN. THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). FROM THE IMAGE REVIEW, POSSIBLE CAUSES FOR THIS OCCURRENCE INCLUDE THE DIFFICULT PATIENT ANATOMY. THE IMAGE REVIEW FOUND THE COMPLAINT STENTS WERE DEPLOYED IN A SEVERELY CALCIFIED, IRREGULAR, AND MODERATE TO SEVERELY NARROW EXTERNAL ILIAC ARTERY (EIA). THIS COULD CAUSE OR CONTRIBUTE TO THE STENTS BECOMING SHORTENING UPON DEPLOYMENT. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER VASCULAR DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (B)(4) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THESE LOT NUMBERS. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1117723 AND C1260575. SUMMARY: THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). THE RISK ASSOCIATED WITH THE COMPLAINT IS NO RISK (CATEGORY III). THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003 . PROBLEM STATEMENT "TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH." DEVICE EVALUATION THE TWO ZIV6-35-125-8-80 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENT, AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE STENT WAS USED WITH A FEMORAL ENDARTERECTOMY IN THE EXTERNAL ILIAC ARTERIES (EIA) FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A POST DEPLOYMENT PTA WAS CONDUCTED, WHICH RESULTED IN EXTRAVASATION OF BLOOD FROM THE STENTED PORTION OF THE VESSEL. ANOTHER STENT WAS PLACED TO COVER THE AREA OF EXTRAVASATION. THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE IMPLANTED STENTS SHORTENING. THE PATIENT ULTIMATELY REQUIRED ADDITIONAL SURGERIES AND EVENTUALLY AMPUTATION OF THE LOWER LIMB. HOWEVER, ACCORDING TO THE DISTRICT MANAGER, THIS WAS LIKELY DUE TO PROGRESSION OF PERIPHERAL VASCULAR DISEASE, DISTAL TO THE FEMORAL ARTERIES. THE CUSTOMER STATED THAT BOTH STENTS WERE MEANT TO BE 80MM LONG. ONE OF THE IMPLANTED STENTS APPEARED TO BE HALF ITS SPECIFIED LENGTH. THE STENTS WERE MEASURED VISUALLY. 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? NO. IMPLANTATION OF A SHORT ZIV6 WAS NOT CONFIRMED . IMPLANTATION OF THE COMPLAINT ZIV6 TO HALF ITS DESIGN LENGTH IS CONFIRMED. THE SHORTENING WAS SECONDARY TO A CONCERTINAED STENT RATHER THAN AN INCORRECTLY PACKAGED STENT. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: THIS TYPE OF MAL-DEPLOYMENT HAS BEEN OBSERVED IN OTHER CASES WHERE STENTS ARE DEPLOYED WITH LIMITED DIAMETER OR NO PRE-IMPLANTATION ANGIOPLASTY IN STENOSES WITH SIMILAR CHARACTERISTICS. THESE CHARACTERISTICS INCLUDE MODERATE TO SEVERE OR WORSE STENOSES CONTAINING HEAVILY CALCIFIED IRREGULAR PLAQUE. RATHER THAN BEING ALLOWED TO EXPAND WITHOUT CONTACTING PLAQUE UNTIL RELATIVELY PARALLEL TO THE LUMEN, THE PLAQUE TURNS EACH STENT ROW PERPENDICULAR TO THE LUMEN. THIS CONTINUOUS SHORTENING OF THE DEPLOYING STENT EXTRACTS THE STENT FROM THE DEPLOYMENT SHEATH. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: NONE. OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: THE ORIGINAL STENT'S SEVERE CONSTRAINT AND BOTH STENTS' IMPROVEMENT AFTER ANGIOPLASTY INDICATE THAT ANGIOPLASTY PRIOR TO IMPLANTATION OF THE FIRST STENT WAS NOT PERFORMED. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE. FINDINGS: 1. TWO ANGIOGRAPHIC IMAGES PHOTOGRAPHED OFF A MONITOR ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE FIRST IMAGE IS A MAGNIFIED, SUBTRACTED AP (ANTERIOR/ POSTERIOR PROJECTION) IMAGE OF THE RECENTLY DEPLOYED COMPLAINT ZIV6. THE ZIV6 HAD BEEN IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA) FROM A RIGHT COMMON FEMORAL ARTERY (CFA) ACCESS. 3. THE SECOND IMAGE IS AN UNSUBTRACTED, SLIGHTLY LESS MAGNIFIED AP IMAGE TAKEN DURING ANGIOPLASTY OF THE SECOND ZIV6. 4. ALTHOUGH EXACT CALIBRATION IS NOT POSSIBLE, THE POST IMPLANTATION ANGIOPLASTY BALLOON APPEARED TO BE AN 8MMX60MM BALLOON. THE FEMORAL HEAD WAS IMAGED ENOUGH TO ASCERTAIN ITS DIAMETER. A NORMAL FEMORAL HEAD DIAMETER IS 42MM. ONLY A 60CM LONG BALLOON MATCHED A NORMAL FEMORAL HEAD DIAMETER. THE BALLOON COULD NOT HAVE BEEN 80MM LONG; OTHERWISE, ITS DIAMETER WOULD HAVE MEASURED LARGER THAN THE 8MM DIAMETER ZIV6 AND THE FEMORAL HEAD WOULD HAVE MEASURED MUCH LARGER THAN THE LARGEST OF HUMANS. LIKEWISE, THE BALLOON DID NOT APPEAR 40MM LONG AND IF 40MM, THE FEMORAL HEAD WOULD HAVE BEEN MUCH SMALLER THAN THE SMALLEST OF HUMANS. 5. ASSUMING A 60MM LONG BALLOON, THE FIRST ZIV6 WAS DEPLOYED IN A SEVERELY CALCIFIED, IRREGULAR, AND MODERATE TO SEVERELY NARROWED EIA. THE ZIV6 WAS CONCERTINAED TO 40MM AND CENTRALLY COMPRESSED TO 40MM. THE ZIV6'S ENDS WERE NARROWED TO 3MM AND SO DISTORTED FROM LUMEN IRREGULARITY THAT THEY WERE UNRECOGNIZABLE AS CIRCULAR ENDS. INSTEAD, THE END MARKERS WERE SEPARATED BY AS MUCH AS 7MM ALONG THE LENGTH OF THE ARTERY. 6. THE SECOND ZIV6 WAS IMPLANTED INSIDE THE FIRST. ITS IMPLANTED LENGTH WAS 65MM. IT EXTENDED FROM THE PROXIMAL END OF THE FIRST ZIV6 TO 2.5CM BEYOND THE FIRST ZIV6'S DISTAL END. 7. THE ANGIOPLASTY BALLOON EXTENDED FROM THE MID FIRST ZIV6 INFERIORLY TO THE EIA/ CFA JUNCTION. IT WAS FULLY EXPANDED EXCEPT EACH END WHERE IT WAS STILL 20% CONSTRAINED . 8. FROM THE MID FIRST ZIV6 SUPERIORLY, ALTHOUGH SIGNIFICANTLY IMPROVED, BOTH STENTS WERE STILL CONSTRAINED OVER 30%. THE ORIGINAL STENT'S SEVERE CONSTRAINT AND BOTH STENTS' IMPROVEMENT AFTER ANGIOPLASTY INDICATE THAT ANGIOPLASTY PRIOR TO IMPLANTATION OF THE FIRST STENT WAS NOT PERFORMED. IMPRESSION: 1. IMPLANTATION OF A SHORT STENT WAS NOT CONFIRMED. IMPLANTATION OF THE COMPLAINT STENT TO HALF ITS DESIGN LENGTH IS CONFIRMED. THE SHORTENING WAS SECONDARY TO A CONCERTINAED STENT RATHER THAN AN INCORRECTLY PACKAGED STENT. THIS TYPE OF MALDEPLOYMENT HAS BEEN OBSERVED IN OTHER CASES WHERE STENTS ARE DEPLOYED WITH LIMITED DIAMETER OR NO PRE-IMPLANTATION ANGIOPLASTY IN STENOSES WITH SIMILAR CHARACTERISTICS. THESE CHARACTERISTICS INCLUDE MODERATE TO SEVERE OR WORSE STENOSES CONTAINING HEAVILY CALCIFIED IRREGULAR PLAQUE. RATHER THAN BEING ALLOWED TO EXPAND WITHOUT CONTACTING PLAQUE UNTIL RELATIVELY PARALLEL TO THE LUMEN, THE PLAQUE TURNS EACH STENT ROW PERPENDICULAR TO THE LUMEN. THIS CONTINUOUS SHORTENING OF THE DEPLOYING STENT EXTRACTS THE STENT FROM THE DEPLOYMENT SHEATH. 2. ALTHOUGH NOT A SUBJECT OF THE COMPLAINT, THE SECOND STENT ALSO DEPLOYED SHORTER THAN ITS DESIGN LENGTH. THIS LIKELY OCCURRED THROUGH THE SAME MECHANISM EXCEPT THAT IT WAS EXTRACTED BY THE CONCERTINAED FIRST STENT RATHER THAN PLAQUE. THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). FROM THE IMAGE REVIEW, POSSIBLE CAUSES FOR THIS OCCURRENCE INCLUDE THE DIFFICULT PATIENT ANATOMY. THE IMAGE REVIEW FOUND THE COMPLAINT STENTS WERE DEPLOYED IN A SEVERELY CALCIFIED, IRREGULAR, AND MODERATE TO SEVERELY NARROW EXTERNAL ILIAC ARTERY (EIA). THIS COULD CAUSE OR CONTRIBUTE TO THE STENTS BECOMING SHORTENING UPON DEPLOYMENT. HOWEVER, AS THE DEVICES ARE NOT AVAILABLE, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT STENTS IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER VASCULAR 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. SUMMARY THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). THE RISK ASSOCIATED WITH THE COMPLAINT IS NO RISK (CATEGORY III). THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Additional Manufacturer Narrative · 0

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)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. ADDITIONAL INFORMATION: THERE ARE TWO DEVICES RELATED TO THIS COMPLAINT. THE TWO ZIV6-35-125-8-80 STENTS WERE OF DIFFERENT LOT NUMBERS C1117723 (B)(4) AND C1260575 (B)(4). FOR DETAILS OF THE SECOND DEVICE REFER TO (B)(4).

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

Additional Manufacturer Narrative · 0

COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

Additional Manufacturer Narrative · 0

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) # OF SIMILAR DEVICE: P050017/S002 AND S003. . PROBLEM STATEMENT: "TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH." DEVICE EVALUATION: THE TWO ZIV6-35-125-8-80 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENT, AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE CUSTOMER WAS CONTACTED TO CONFIRM THE PRODUCT LOT CODES, DETAILS OR IMAGES OF THE PROCEDURE, AND HOW THE COMPLAINT DEVICE WAS MEASURED. AT THE TIME OF THE INVESTIGATION, THE INFORMATION HAD NOT YET BEEN PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE INFORMATION IS PROVIDED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PROCEDURAL METHOD, SUCH AS DEVICE HANDLING DURING DEPLOYMENT, OR A DIFFICULT PATIENT ANATOMY. THESE FACTORS COULD CAUSE OR CONTRIBUTE TO THE STENTS BECOMING ELONGATED OR COMPRESSED DURING OR AFTER DEPLOYMENT. HOWEVER, AS THE DEVICES ARE NOT AVAILABLE, THE INFORMATION HAS NOT YET BEEN PROVIDED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER VASCULAR 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. IT MAY BE NOTED THAT THE FAILURE MODE OF "STENT LENGTH INCORRECT" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED WHEN THE IMAGES OR ADDITIONAL INFORMATION HAS BEEN RECEIVED. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WILL BE ASSESSED FOR THIS COMPLAINT WHEN THE IMAGES OR ADDITIONAL INFORMATION HAVE BEEN PROVIDED, AND ONCE COMPLETED THE INVESTIGATION WILL BE UPDATED WITH THE RISK DETAILS. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.