ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00405
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- August 3, 2018
- Report Date
- September 26, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384900
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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 IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510 (K) NUMBER: 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. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER: 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 F.3 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT "AS REPORTED TO CUSTOMER RELATIONS, "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."" DEVICE EVALUATION. THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1396710 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM THE INFORMATION PROVIDED, A 6X55 ANSEL ACCESS SHEATH AND A 0.035¿ AQUALINER WIRE GUIDE WERE USED WITH THE DEVICE. THE DEVICE WAS FLUSHED THROUGH BOTH FLUSHING PORTS AS PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET SITE WAS CONFIRMED AS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ADVANCED VIA CONTRALATERAL APPROACH TO THE SFA. THE BIFURCATION WAS DESCRIBED AS NORMAL. THE PATIENT¿S ANATOMY WAS DESCRIBED AS TORTUOUS TO THE TARGET SITE BUT THE TARGET SITE ITSELF WAS NOT TORTUOUS. THE DEVICE WAS ADVANCED THROUGH A STENT THAT HAD BEEN PLACED IN A PREVIOUS PROCEDURE. THE OCCLUSION TO BE TREATED WITH THE COMPLAINT DEVICE WAS DISTAL TO THE PREVIOUSLY PLACED STENT. THE PREVIOUS STENT WAS BALLOONED AND THE COMPLAINT DEVICE WAS ADVANCED. PRE-DILATION WAS CONDUCTED PRIOR TO STENT PLACEMENT. APPROXIMATELY HALF OF THE STENT DEPLOYED AND FRACTURED IN THE PATIENT. THE CUSTOMER CONFIRMED ADVANCEMENT TO THE LESION WAS NOT DIFFICULT. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 06 SEPTEMBER 2018. ON EVALUATION OF THE RETURNED DEVICE, THE FLLA COMPONENT WAS BROKEN AND THE STENT RETRACTION WIRE WAS SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). KINKS WERE OBSERVED ON THE SHEATH. APPROXIMATELY 10.5 CM OF THE STENT WAS RETURNED IN THE SHEATH. THE PROXIMAL INNER WAS CUT AT THE FIRST SPIRAL CUT. HALF OF THE HANDLE AND THE FLLA TIP WERE NOT RETURNED. THE CUSTOMER WAS CONTACTED TO DETERMINE IF THERE WERE ANY ISSUES WITH THE FLLA PORT PRIOR TO ADVANCING THE DEVICE. IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE FLLA BEFORE THE PROCEDURE BUT THE FLLA COMPONENT MAY HAVE BEEN DAMAGED WHEN THE PHYSICIAN TOOK THE HANDLE APART IN AN ATTEMPT TO DEPLOY THE STENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS SEPARATED FROM THE SRS. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE DIFFICULT PATIENT ANATOMY AND/OR ADVANCING THE STENT THROUGH A PREVIOUSLY PLACED STENT. TORTUOUS PATIENT ANATOMY AND/OR ADVANCING THE DEVICE THROUGH A PREVIOUSLY PLACED STENT COULD HAVE CAUSED OR CONTRIBUTED TO SOME RESISTANCE DURING ADVANCEMENT/DEPLOYMENT. THE RESISTANCE COULD HAVE CAUSED OR CONTRIBUTED TO HIGH DEPLOYMENT FORCES DURING DEPLOYMENT RESULTING IN SEPARATION OF THE RETRACTION WIRE FROM THE SRS. 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. IT MAY BE NOTED THAT 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 THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1396710 CONTAINS ZVSPG-T-35-125-7-120-IS OF LOT NUMBERS CH1376363 AND CH1380035. PRIOR TO DISTRIBUTION ALL ZISV6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1396710, CH1376363 AND CH1380035) 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 C1396710. SUMMARY. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS SEPARATED FROM THE SRS. THE RISK FOR THIS COMPLAINT IS RISK CATEGORY III/LOW. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
510 (K) NUMBER: P100022/S014. THIS MDR IS BEING SUBMITTED UNDER FOLLOW UP #3 HOWEVER IT IS ACTUALLY THE SECOND FOLLOW UP REPORT SUBMITTED UNDER FOR THIS FILE. THE FOLLOW UP #1 MDR SUBMITTED PREVIOUSLY HAD INDICATED THAT IT WAS THE SECOND FOLLOW UP IN ERROR, THIS IS TO CORRECT THIS ERROR. 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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PROBLEM STATEMENT: "AS REPORTED TO CUSTOMER RELATIONS, "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."" DEVICE EVALUATION: THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1396710 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM THE INFORMATION PROVIDED, A 6X55 ANSEL ACCESS SHEATH AND A 0.035¿ AQUALINER WIRE GUIDE WERE USED WITH THE DEVICE. THE DEVICE WAS FLUSHED THROUGH BOTH FLUSHING PORTS AS PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET SITE WAS CONFIRMED AS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ADVANCED VIA CONTRALATERAL APPROACH TO THE SFA. THE BIFURCATION WAS DESCRIBED AS NORMAL. THE PATIENT¿S ANATOMY WAS DESCRIBED AS TORTUOUS TO THE TARGET SITE BUT THE TARGET SITE ITSELF WAS NOT TORTUOUS. THE DEVICE WAS ADVANCED THROUGH A STENT THAT HAD BEEN PLACED IN A PREVIOUS PROCEDURE. THE OCCLUSION TO BE TREATED WITH THE COMPLAINT DEVICE WAS DISTAL TO THE PREVIOUSLY PLACED STENT. THE PREVIOUS STENT WAS BALLOONED AND THE COMPLAINT DEVICE WAS ADVANCED. PRE-DILATION WAS CONDUCTED PRIOR TO STENT PLACEMENT. APPROXIMATELY HALF OF THE STENT DEPLOYED AND FRACTURED IN THE PATIENT. THE CUSTOMER CONFIRMED ADVANCEMENT TO THE LESION WAS NOT DIFFICULT. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 06 SEPTEMBER 2018. ON EVALUATION OF THE RETURNED DEVICE, THE FLLA COMPONENT WAS BROKEN AND THE STENT RETRACTION WIRE WAS SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). KINKS WERE OBSERVED ON THE SHEATH. APPROXIMATELY 10.5 CM OF THE STENT WAS RETURNED IN THE SHEATH. THE PROXIMAL INNER WAS CUT AT THE FIRST SPIRAL CUT. HALF OF THE HANDLE AND THE FLLA TIP WERE NOT RETURNED. THE CUSTOMER WAS CONTACTED TO DETERMINE IF THERE WERE ANY ISSUES WITH THE FLLA PORT PRIOR TO ADVANCING THE DEVICE. IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE FLLA BEFORE THE PROCEDURE BUT THE FLLA COMPONENT MAY HAVE BEEN DAMAGED WHEN THE PHYSICIAN TOOK THE HANDLE APART IN AN ATTEMPT TO DEPLOY THE STENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS SEPARATED FROM THE SRS. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE DIFFICULT PATIENT ANATOMY AND/OR ADVANCING THE STENT THROUGH A PREVIOUSLY PLACED STENT. TORTUOUS PATIENT ANATOMY AND/OR ADVANCING THE DEVICE THROUGH A PREVIOUSLY PLACED STENT COULD HAVE CAUSED OR CONTRIBUTED TO SOME RESISTANCE DURING ADVANCEMENT/DEPLOYMENT. THE RESISTANCE COULD HAVE CAUSED OR CONTRIBUTED TO HIGH DEPLOYMENT FORCES DURING DEPLOYMENT RESULTING IN SEPARATION OF THE RETRACTION WIRE FROM THE SRS. 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. IT MAY BE NOTED THAT 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: THE ZISV6-35-125-7-120-PTX DEVICE OF LOT NUMBER C1396710 CONTAINS ZVSPG-T-35-125-7-120-IS OF LOT NUMBERS CH1376363 AND CH1380035. PRIOR TO DISTRIBUTION ALL ZISV6 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 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 C1396710. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS SEPARATED FROM THE SRS. THE RISK FOR THIS COMPLAINT IS RISK CATEGORY III/LOW. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
REPORT IS BEING SUBMITTED AS IT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. ALSO REPORTABLE UNDER THE PRECEDENCE FOR "THUMBWHEEL MALFUNCTIONS" "DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT" AND "STENT FRACTURE". "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."
AS REPORTED TO CUSTOMER RELATIONS, "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."
AS REPORTED TO CUSTOMER RELATIONS, "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."
AS REPORTED TO CUSTOMER RELATIONS, "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670342 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38490 | C1396710 | 10827002384900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |