ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00068
- Event Type
- Injury
- Date Received
- February 22, 2018
- Date of Event
- January 25, 2018
- Report Date
- May 1, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384825
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. PROBLEM STATEMENT: PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THEY HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE." DEVICE EVALUATION: THE ZISV6-35-125-6-120-PTX DEVICE OF LOT NUMBER C1438412 INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE CUSTOMER REPRESENTATIVE WILL CONTACT THE CUSTOMER TO ASK IF IMAGES OF THE PROCEDURE ARE AVAILABLE. THE COMPLAINT DEVICE IS TO BE RETURNED. THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE OR IMAGES HAVE BEEN RETURNED AND EVALUATED. THE COMPLAINT DEVICE WAS ADVANCED VIA A CONTRALATERAL APPROACH. THE DELIVERY SYSTEM SHEATH WAS IN THE ACCESS SHEATH DURING DEPLOYMENT. THE CUSTOMER CONFIRMED THAT THE TARGET LESION FOR THE DEVICE WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE DEVICE WAS FLUSHED PRIOR TO USE. THE DETAILS OF THE WIRE GUIDE USED WITH THE DEVICE ARE NOT KNOWN. THE PATIENT HAD A CALCIFIED ILIAC ARTERY. PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT PARTIALLY DEPLOYED IN THE PATIENT, AND A PORTION OF THE STENT HAD TO BE REMOVED VIA SURGICAL INTERVENTION. 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 CALCIFIED PATIENT ANATOMY. THE CALCIFIED ILIAC ARTERY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT, AND CAUSED OR CONTRIBUTED TO THE PARTIAL STENT DEPLOYMENT. THE STENT COULD HAVE BROKEN AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. HOWEVER, AS THE DEVICE HAVE 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: 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. IT MAY BE NOTED THAT THE FAILURE MODE OF "DEPLOYMENT DIFFICULT" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED FOLLOWING DEVICE RETURN AND EVALUATION. 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 DEVICE IS RETURNED AND EVALUATED, AND ONCE COMPLETED THE INVESTIGATION WILL BE UPDATED WITH THE RISK DETAILS. ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN HAD TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE FRACTURED STENT PORTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. H3 OTHER TEXT : 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: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS.
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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THEY HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE." DEVICE EVALUATION THE ZISV6-35-125-6-120-PTX DEVICE 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. THE CUSTOMER CONFIRMED THAT IMAGES ARE AVAILABLE. AT THE TIME OF THE INVESTIGATION, THE IMAGES HAVE NOT BEEN PROVIDED. THE INVESTIGATION WILL BE UPDATED WHEN THE IMAGES ARE PROVIDED AND EVALUATED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE DEVICE WAS FLUSHED PRIOR TO USE. THE PATIENT HAD A CALCIFIED ILIAC ARTERY. PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. FROM CUSTOMER TESTIMONY, IT KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A CONTRA-LATERAL APPROACH. THE TARGET LESION FOR THE DEVICE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS BEING TREATED FOR AN IN STENT RESTENOSIS (ISR). THE DELIVERY SYSTEM SHEATH WAS IN THE ACCESS SHEATH DURING DEPLOYMENT. THE ACCESS SHEATH WAS AN ANSEL BRAND SHEATH, AND THE SHEATH COULD NOT ADVANCE OVER THE BIFURCATION, POSSIBLY DUE TO THE STEEP BIFURCATION AND CALCIFICATION. THE SHEATH WAS IN THE COMMON ILIAC ARTERY DURING DEVICE DEPLOYMENT. THE PHYSICIAN INITIALLY ADVANCED A 0.035¿ DIAMETER WIRE GUIDE, BUT EXCHANGED THIS FOR A 0.018¿ DIAMETER WIRE GUIDE TO PASS THROUGH THE LESION, AND WAS EVENTUALLY ADVANCED INTO THE TIBIAL VESSEL. THE TARGET LESION WAS TREATED WITH A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WITH A 2, 3 AND FINALLY 5MM DIAMETER BALLOON. THE COMPLAINT DEVICE DID NOT ENCOUNTER RESISTANCE DURING ADVANCEMENT. THE PHYSICIAN DID NOT ENCOUNTER RESISTANCE DURING DEPLOYMENT. ABOUT HALF OF THE STENT DEPLOYED BEFORE THE THUMBWHEEL MECHANISM FAILED. THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM, CAUSING THE STENT TO FRACTURE AND THE DELIVERY SYSTEM CATHETER TO BREAK. THE PHYSICIAN SPENT THREE HOURS ATTEMPTING TO SNARE AND REMOVE THE BROKEN PORTIONS OF THE STENT AND DELIVERY SYSTEM. THE PATIENT BEGAN TO DEVELOP BLEEDING AND HEART FAILURE, SO THE PROCEDURE WAS STOPPED. THE FRACTURED STENT PORTION WAS REMOVED THE FOLLOWING DAY IN AN OPEN PROCEDURE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6)2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITHOUT THE DISTAL WHITE TIP, A DISTAL PORTION OF THE STENT RETRACTION SHEATH (SRS), AND A PORTION OF THE COILED DISTAL INNER. CRINKLES WERE OBSERVED ON THE DISTAL SRS WITH 5MM PITCH. MULTIPLE KINKS WERE FOUND ON THE SRS AND STABILITY SHEATH (SS). THE SS WAS 86.2CM LONG, AND KINKED JUST DISTAL TO THE STRAIN RELIEF. THE DEVICE WAS RETURNED WITH THE HANDLE INTACT. THE HANDLE WAS OPENED, AND THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. A PORTION OF THE PROXIMAL INNER WAS SEEN INSIDE THE SS. THE DISTRICT MANAGER STATED THAT THE BOTH THE STENT AND A PORTION OF THE DELIVERY SYSTEM BROKE OFF IN THE PATIENT. THE CUSTOMER WILL NOT BE RETURNING THE BROKEN PORTIONS OF THE DELIVERY SYSTEM. THE ENTIRE DEVICE WAS EVENTUALLY REMOVED FROM THE PATIENT. WHILE THE PATIENT HAD A PREVIOUSLY PLACED LIFE STENT, THERE WERE NO STENTS IN THE ACCESS PATHWAY, SO THE COMPLAINT DEVICE DID NOT CATCH ON A PREVIOUSLY PLACED STENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE CALCIFIED PATIENT ANATOMY OR TIGHT BIFURCATION, OR THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE CUSTOMER ALSO STATED THAT THE ACCESS SHEATH WAS NOT ENTIRELY OVER THE BIFURCATION PRIOR TO DEPLOYMENT. THE DIFFICULT ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT, AND THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. THE ACCESS SHEATH NOT BEING OVER THE BIFURCATION COULD HAVE CREATED THE KINKS IN THE SHEATHS OBSERVED IN THE LAB. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH. THE STENT AND DELIVERY SYSTEM COULD HAVE BROKEN AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. HOWEVER, AS THE IMAGES HAVE NOT YET BEEN PROVIDED, 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 (PR216126) 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 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 PHYSICIAN HAD TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE FRACTURED STENT PORTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. 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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THEY HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE." DEVICE EVALUATION THE ZISV6-35-125-6-120-PTX DEVICE 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. THE CUSTOMER CONFIRMED THAT IMAGES ARE AVAILABLE. AT THE TIME OF THE INVESTIGATION, THE IMAGES HAVE NOT BEEN PROVIDED. THE INVESTIGATION WILL BE UPDATED WHEN THE IMAGES ARE PROVIDED AND EVALUATED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE DEVICE WAS FLUSHED PRIOR TO USE. THE PATIENT HAD A CALCIFIED ILIAC ARTERY. PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. FROM CUSTOMER TESTIMONY, IT KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A CONTRA-LATERAL APPROACH. THE TARGET LESION FOR THE DEVICE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS BEING TREATED FOR AN IN STENT RESTENOSIS (ISR). THE DELIVERY SYSTEM SHEATH WAS IN THE ACCESS SHEATH DURING DEPLOYMENT. THE ACCESS SHEATH WAS AN ANSEL BRAND SHEATH, AND THE SHEATH COULD NOT ADVANCE OVER THE BIFURCATION, POSSIBLY DUE TO THE STEEP BIFURCATION AND CALCIFICATION. THE SHEATH WAS IN THE COMMON ILIAC ARTERY DURING DEVICE DEPLOYMENT. THE PHYSICIAN INITIALLY ADVANCED A 0.035¿ DIAMETER WIRE GUIDE, BUT EXCHANGED THIS FOR A 0.018¿ DIAMETER WIRE GUIDE TO PASS THROUGH THE LESION, AND WAS EVENTUALLY ADVANCED INTO THE TIBIAL VESSEL. THE TARGET LESION WAS TREATED WITH A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WITH A 2, 3 AND FINALLY 5MM DIAMETER BALLOON. THE COMPLAINT DEVICE DID NOT ENCOUNTER RESISTANCE DURING ADVANCEMENT. THE PHYSICIAN DID NOT ENCOUNTER RESISTANCE DURING DEPLOYMENT. ABOUT HALF OF THE STENT DEPLOYED BEFORE THE THUMBWHEEL MECHANISM FAILED. THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM, CAUSING THE STENT TO FRACTURE AND THE DELIVERY SYSTEM CATHETER TO BREAK. THE PHYSICIAN SPENT THREE HOURS ATTEMPTING TO SNARE AND REMOVE THE BROKEN PORTIONS OF THE STENT AND DELIVERY SYSTEM. THE PATIENT BEGAN TO DEVELOP BLEEDING AND HEART FAILURE, SO THE PROCEDURE WAS STOPPED. THE FRACTURED STENT PORTION WAS REMOVED THE FOLLOWING DAY IN AN OPEN PROCEDURE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6)2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITHOUT THE DISTAL WHITE TIP, A DISTAL PORTION OF THE STENT RETRACTION SHEATH (SRS), AND A PORTION OF THE COILED DISTAL INNER. CRINKLES WERE OBSERVED ON THE DISTAL SRS WITH 5MM PITCH. MULTIPLE KINKS WERE FOUND ON THE SRS AND STABILITY SHEATH (SS). THE SS WAS 86.2CM LONG, AND KINKED JUST DISTAL TO THE STRAIN RELIEF. THE DEVICE WAS RETURNED WITH THE HANDLE INTACT. THE HANDLE WAS OPENED, AND THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. A PORTION OF THE PROXIMAL INNER WAS SEEN INSIDE THE SS. THE DISTRICT MANAGER STATED THAT THE BOTH THE STENT AND A PORTION OF THE DELIVERY SYSTEM BROKE OFF IN THE PATIENT. THE CUSTOMER WILL NOT BE RETURNING THE BROKEN PORTIONS OF THE DELIVERY SYSTEM. THE ENTIRE DEVICE WAS EVENTUALLY REMOVED FROM THE PATIENT. WHILE THE PATIENT HAD A PREVIOUSLY PLACED LIFE STENT, THERE WERE NO STENTS IN THE ACCESS PATHWAY, SO THE COMPLAINT DEVICE DID NOT CATCH ON A PREVIOUSLY PLACED STENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE CALCIFIED PATIENT ANATOMY OR TIGHT BIFURCATION, OR THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE CUSTOMER ALSO STATED THAT THE ACCESS SHEATH WAS NOT ENTIRELY OVER THE BIFURCATION PRIOR TO DEPLOYMENT. THE DIFFICULT ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT, AND THE WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. THE ACCESS SHEATH NOT BEING OVER THE BIFURCATION COULD HAVE CREATED THE KINKS IN THE SHEATHS OBSERVED IN THE LAB. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH. THE STENT AND DELIVERY SYSTEM COULD HAVE BROKEN AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. HOWEVER, AS THE IMAGES HAVE NOT YET BEEN PROVIDED, 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 (PR216126) 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 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 PHYSICIAN HAD TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE FRACTURED STENT PORTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. PMA/510(K) #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS.
PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THE HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THE HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION DUE TO DEVICE RETURN PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THE HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. PER EMAIL, "STENT MALFUNCTIONED AND WOULD NOT PROPERLY DEPLOY." AS REPORT PER PHONE CALL, "AS THEY WERE DEPLOYING, IT STOPPED DUE TO CALCIFICATION. THEY WERE ABLE TO PARTIALLY DEPLOY THE DEVICE; HOWEVER, A PORTION OF IT BROKE OFF IN THE PATIENT. THE HAD TO DO A CUT DOWN TO RETRIEVE THE BROKEN PART OF THE DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133551 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38482 | 10827002384825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |