ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00139
- Event Type
- Malfunction
- Date Received
- March 20, 2018
- Date of Event
- February 20, 2018
- Report Date
- April 17, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384863
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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/S001. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
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) # P100022/S001. PROBLEM STATEMENT: AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE." DEVICE EVALUATION: THE ZISV6-35-125-7-40-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. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A BOSTON SCIENTIFIC WIRE GUIDE OF 0.018¿ DIAMETER. THERE WAS NO EVIDENCE OF STENT COMPRESSION OR DEFORMATION AFTER DEPLOYMENT. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS, BUT WAS HEAVILY CALCIFIED. THE DEVICE ADVANCED WITHOUT RESISTANCE. THE DEVICE WAS FLUSHED PRIOR TO USE, AND PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT DEPLOYED IN THE PATIENT. THE DISTRICT MANAGER PROVIDED THE FOLLOWING STATEMENTS: ¿THE PHYSICIAN DEPLOYED THE STENT FROM AN IPSILATERAL APPROACH. THEREFORE, MAJORITY OF THE STENT SHEATH WAS OUTSIDE THE PATIENT¿S BODY. IN ADDITION, HIS HAND WAS PLACED ON THE SHEATH (WHAT I THOUGHT WAS AT LEAST 40CM FROM THE TIP) HOWEVER I CANNOT BE SURE OF THE EXACT DISTANCE. IN THIS PARTICULAR CASE, THE PHYSICIANS HAND BEING PLACED ON THE SHEATH (IF IT WAS ON THE RETRACTION PORTION) MAY HAVE CAUSED CHALLENGES WITH THE THUMBWHEEL¿. ¿THE DOCTOR TREATED THIS PATIENT BY USING AN IPSILATERAL, RETROGRADE APPROACH AND DEPLOYED THE STENT IN THE COMMON FEMORAL ARTERY. THE SHEATH THAT WAS USED WAS 6 FRENCH 10 CENTIMETERS LONG. I WILL ADD THAT THE PHYSICIAN DID HAVE HIS HAND ON THE RETRACTION SHEATH (UNINTENTIONALLY OF COURSE) BUT WE DO BELIEVE THAT THIS MAY HAVE BEEN THE CAUSE OF THIS DEPLOYMENT FAILURE¿. 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. THE COMPLAINT CANNOT BE CONFIRMED AS IMAGING FROM DEPLOYMENT OR AN EXPLANATION AS TO HOW THE STENT WAS DEPLOYED WAS NOT PROVIDED. THE STENT WAS SUCCESSFULLY IMPLANTED TO ITS DESIGN LENGTH MINUS THE DISTORTION OF EACH END. THIS DISTORTION WAS LIKELY DUE TO THE LESION RATHER THAN DEPLOYMENT DIFFICULTY. IT IS ALSO UNCLEAR HOW THE REPORTED DEPLOYMENT DIFFICULTY REQUIRED ADDITIONAL ANGIOPLASTY WHEN THE PLAQUE RECOIL NECESSITATED ADDITIONAL ANGIOPLASTY. 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: NONE. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE. FINDINGS: MULTIPLE IMAGES FROM IMPLANTATION ANGIOGRAPHY ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. IMAGE QUALITY IS VERY LIMITED. NO TIME STAMPS WERE INCLUDED. THE LARGEST IMAGE, INCLUDING VIDEO, IS LESS THAN ONE HALF A MEGABYTE. A TOTAL OF 56, EITHER STILL IMAGES OR SHORT VIDEO CLIPS OF ANGIOGRAPHY, WERE PROVIDED. UP THROUGH IMAGE 50 THESE APPEAR TO BE IN SEQUENCE. THE PROCEDURE BEGAN WITH RIGHT RADIAL ACCESS TO A RIGHT COMMON FEMORAL ARTERY (CFA) STENOSIS PROXIMAL TO A NEAR OCCLUSIVE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) ORIGIN STENOSIS. AN ECCENTRIC MOUND SHAPED, HEAVILY CALCIFIED RIGHT CFA PLAQUE WAS TREATED WITH ORBITAL ATHERECTOMY. SUBSEQUENT ATTEMPTS AT ADVANCING A WIRE FROM THE RADIAL ARTERY SHEATH THROUGH THE NEARLY OCCLUDED SFA ORIGIN WERE UNSUCCESSFUL. RETROGRADE SFA PERCUTANEOUS ACCESS WAS OBTAINED APPROXIMATELY 9CM INFERIOR TO THE SFA ORIGIN AND THE OCCLUSION CROSS FROM BELOW. ANGIOPLASTY OF THE CFA AND SFA FOLLOWED. THIS SIGNIFICANTLY IMPROVED THE SFA ORIGIN STENOSIS: HOWEVER, A LARGE, HEAVILY CALCIFIED ECCENTRIC MOUND SHAPED PLAQUE REMAINED. ADDITIONAL ANGIOPLASTY RESULTED IN RUPTURE OF THE CFA LATERAL WALL OPPOSITE THE PLAQUE. THIS WAS FOLLOWED BY BALLOON EXPANDABLE STENT IMPLANTATION IN THE RIGHT COMMON ILIAC ARTERY THROUGH THE RIGHT SFA SHEATH. A SUPERA STENT WAS THEN IMPLANTED IN THE RIGHT CFA, ALTHOUGH IT COVERED OVER THE PROXIMAL AND MID CFA PLAQUE BUT LANDED SHORT OF THE MOST SIGNIFICANT MOUND SHAPED PLAQUE IN THE DISTAL CFA. THE SUPERA STENT IS VERY DIFFICULT TO PRECISELY IMPLANT. THE ZISV6-35-125-7-40-PTX STENT WAS IMPLANTED FROM THE PROXIMAL END OF THE SUPERA STENT OVER THE MISSED MOUND SHAPED PLAQUE. THE SHEATH PRESENT AT THE TIME APPEARED DIFFERENT THAN THE SHEATH IN PLACE DURING THE ANGIOPLASTY AND WAS CONSISTENT WITH A 7F FLEXOR SHEATH. THE SHEATH TIP NEVER EXTENDED INTO THE RIGHT CFA, SUGGESTING IT WAS INSERTED TO ITS HUB. BECAUSE THE ACCESS WAS 9CM INFERIOR TO THE SFA ORIGIN, IT IS VERY UNLIKELY THE SHEATH WAS 10CM LONG. THE SHEATH WAS LIKELY BETWEEN 15 AND 25CM LONG. THE ZISV6-35-125-7-40-PTX STENT ENDS WERE SLIGHTLY DISTORTED, CONSISTENT WITH IMPLANTATION IN ANGIOPLASTY RESISTANT, MOUND SHAPED PLAQUE. THE STENT LENGTH WAS 40MM FROM TIP TO TIP ALTHOUGH DISTORTION OF THE ENDS LIMITED CIRCUMFERENTIAL STENT COVERAGE TO A LENGTH OF 35MM. THE ZISV6-35-125-7-40-PTX IMPROVED BUT DID NOT COMPLETELY RESOLVE THE PLAQUE EVEN AFTER ANGIOPLASTY. THE CFA RUPTURE DID NOT RESOLVE. ONE IMAGE SUGGESTS A THIRD STENT, UNLIKELY A ZILVER, WAS IMPLANTED INSIDE THE ZISV6-35-125-7 -40-PTX. IMPRESSION: THE COMPLAINT CANNOT BE CONFIRMED AS IMAGING FROM DEPLOYMENT OR AN EXPLANATION AS TO HOW THE STENT WAS DEPLOYED WAS NOT PROVIDED. THE STENT WAS SUCCESSFULLY IMPLANTED TO ITS DESIGN LENGTH MINUS THE DISTORTION OF EACH END. THIS DISTORTION WAS LIKELY DUE TO THE LESION RATHER THAN DEPLOYMENT DIFFICULTY. IT IS ALSO UNCLEAR HOW THE REPORTED DEPLOYMENT DIFFICULTY REQUIRED ADDITIONAL ANGIOPLASTY WHEN THE PLAQUE RECOIL NECESSITATED ADDITIONAL ANGIOPLASTY. THE SFA ACCESS, ALTHOUGH UNCONVENTIONAL, WAS NOT UNDULY ANGULATED. NO TORTUOSITY WAS PRESENT. ALTHOUGH A 6F, 10CM SHEATH AS MENTIONED IN THE COMPLAINT REPORT MAY HAVE BEEN USED, THE SHEATH THROUGH WHICH THE ZISV6-35-125-7 -40-PTX WAS DEPLOYED WAS LIKELY 7F IN DIAMETER AND 15-25CM LONG. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 20TH MARCH 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED DISASSEMBLED. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). KINKS WERE OBSERVED IN THE STABILITY SHEATH (SS) AND SRS, 32CM, 70CM, 84CM, 90CM AND 104CM FROM THE DISTAL END OF THE SRS, WHICH COULD HAVE OCCURRED DUE TO THE IPSILATERAL APPROACH OR DURING TRANSPORT BACK TO COOK IRELAND. THERE WAS NO TACTILE DAMAGE OBSERVED ON THE SRS, BUT A SLIGHT CRINKLE WAS FOUND ON THE SRS, JUST DISTAL TO THE SRS/SS JOINT. NO PORTION OF THE STENT WAS RETURNED WITH THE DEVICE. FISH MOUTH DAMAGE WAS FOUND 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 (SRS). POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY, THE APPROACH USED AND THE USE OF A NON-RECOMMENDED WIRE GUIDE THE HEAVILY CALCIFIED ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT. THE NON-RECOMMENDED DIAMETER OF WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. THE USE OF A 125CM DEVICE IN AN IPSILATERAL APPROACH MEANT THAT THE STABILITY SHEATH WOULD NOT BE IN THE ACCESS SHEATH DURING DEPLOYMENT, POSSIBLY PROVIDING INSUFFICIENT SUPPORT OR STABILITY DURING DEPLOYMENT OR LEADING TO THE KINKS IN THE SHEATHS. THE PHYSICIAN WAS ALSO REPORTED TO HAVE HAD THEIR HAND ON THE SHEATHS DURING DEPLOYMENT, WHICH COULD HAVE RESULTED IN RESISTANCE DURING DEPLOYMENT. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT RETRACTION WIRE SEPARATING FROM THE STENT 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¿ "ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH." 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 (B)(4). 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 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 (SRS). THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED 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)(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) # P100022/S001. PROBLEM STATEMENT: AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE." DEVICE EVALUATION: THE ZISV6-35-125-7-40-PTX DEVICE OF LOT NUMBER C1430075 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 BOSTON SCIENTIFIC WIRE GUIDE OF 0.018¿ DIAMETER. THERE WAS NO EVIDENCE OF STENT COMPRESSION OR DEFORMATION AFTER DEPLOYMENT. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS, BUT WAS HEAVILY CALCIFIED. THE DEVICE ADVANCED WITHOUT RESISTANCE. THE DEVICE WAS FLUSHED PRIOR TO USE, AND PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT DEPLOYED IN THE PATIENT. THE DISTRICT MANAGER PROVIDED THE FOLLOWING STATEMENTS: ¿THE PHYSICIAN DEPLOYED THE STENT FROM AN IPSILATERAL APPROACH. THEREFORE, MAJORITY OF THE STENT SHEATH WAS OUTSIDE THE PATIENT¿S BODY. IN ADDITION, HIS HAND WAS PLACED ON THE SHEATH (WHAT I THOUGHT WAS AT LEAST 40CM FROM THE TIP) HOWEVER I CANNOT BE SURE OF THE EXACT DISTANCE. IN THIS PARTICULAR CASE, THE PHYSICIANS HAND BEING PLACED ON THE SHEATH (IF IT WAS ON THE RETRACTION PORTION) MAY HAVE CAUSED CHALLENGES WITH THE THUMBWHEEL¿ ¿THE DOCTOR TREATED THIS PATIENT BY USING AN IPSILATERAL, RETROGRADE APPROACH AND DEPLOYED THE STENT IN THE COMMON FEMORAL ARTERY. THE SHEATH THAT WAS USED WAS 6 FRENCH 10 CENTIMETERS LONG. I WILL ADD THAT THE PHYSICIAN DID HAVE HIS HAND ON THE RETRACTION SHEATH (UNINTENTIONALLY OF COURSE) BUT WE DO BELIEVE THAT THIS MAY HAVE BEEN THE CAUSE OF THIS DEPLOYMENT FAILURE¿. IMAGES OF THE PROCEDURE WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES ARE REVIEWED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 20TH MARCH 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED DISASSEMBLED. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). KINKS WERE OBSERVED IN THE STABILITY SHEATH (SS) AND SRS, 32CM, 70CM, 84CM, 90CM AND 104CM FROM THE DISTAL END OF THE SRS, WHICH COULD HAVE OCCURRED DUE TO THE IPSILATERAL APPROACH OR DURING TRANSPORT BACK TO COOK IRELAND. THERE WAS NO TACTILE DAMAGE OBSERVED ON THE SRS, BUT A SLIGHT CRINKLE WAS FOUND ON THE SRS, JUST DISTAL TO THE SRS/SS JOINT. NO PORTION OF THE STENT WAS RETURNED WITH THE DEVICE. FISH MOUTH DAMAGE WAS FOUND 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 (SRS). POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY, THE APPROACH USED AND THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE HEAVILY CALCIFIED ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT. THE NON-RECOMMENDED DIAMETER OF WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. THE USE OF A 125CM DEVICE IN AN IPSILATERAL APPROACH MEANT THAT THE STABILITY SHEATH WOULD NOT BE IN THE ACCESS SHEATH DURING DEPLOYMENT, POSSIBLY PROVIDING INSUFFICIENT SUPPORT OR STABILITY DURING DEPLOYMENT OR LEADING TO THE KINKS IN THE SHEATHS. THE PHYSICIAN WAS ALSO REPORTED TO HAVE HAD THEIR HAND ON THE SHEATHS DURING DEPLOYMENT, WHICH COULD HAVE RESULTED IN RESISTANCE DURING DEPLOYMENT. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH. 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¿ "ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH." 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 (SRS). THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. H3 OTHER TEXT : 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) # P100022/S001. PROBLEM STATEMENT: AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE." DEVICE EVALUATION: THE ZISV6-35-125-7-40-PTX DEVICE OF LOT NUMBER C1430075 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 BOSTON SCIENTIFIC WIRE GUIDE OF 0.018¿ DIAMETER. THERE WAS NO EVIDENCE OF STENT COMPRESSION OR DEFORMATION AFTER DEPLOYMENT. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS, BUT WAS HEAVILY CALCIFIED. THE DEVICE ADVANCED WITHOUT RESISTANCE. THE DEVICE WAS FLUSHED PRIOR TO USE, AND PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT DEPLOYED IN THE PATIENT. THE DISTRICT MANAGER PROVIDED THE FOLLOWING STATEMENTS: ¿THE PHYSICIAN DEPLOYED THE STENT FROM AN IPSILATERAL APPROACH. THEREFORE, MAJORITY OF THE STENT SHEATH WAS OUTSIDE THE PATIENT¿S BODY. IN ADDITION, HIS HAND WAS PLACED ON THE SHEATH (WHAT I THOUGHT WAS AT LEAST 40CM FROM THE TIP) HOWEVER I CANNOT BE SURE OF THE EXACT DISTANCE. IN THIS PARTICULAR CASE, THE PHYSICIANS HAND BEING PLACED ON THE SHEATH (IF IT WAS ON THE RETRACTION PORTION) MAY HAVE CAUSED CHALLENGES WITH THE THUMBWHEEL¿ ¿THE DOCTOR TREATED THIS PATIENT BY USING AN IPSILATERAL, RETROGRADE APPROACH AND DEPLOYED THE STENT IN THE COMMON FEMORAL ARTERY. THE SHEATH THAT WAS USED WAS 6 FRENCH 10 CENTIMETERS LONG. I WILL ADD THAT THE PHYSICIAN DID HAVE HIS HAND ON THE RETRACTION SHEATH (UNINTENTIONALLY OF COURSE) BUT WE DO BELIEVE THAT THIS MAY HAVE BEEN THE CAUSE OF THIS DEPLOYMENT FAILURE¿. IMAGES OF THE PROCEDURE WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES ARE REVIEWED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 20TH MARCH 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED DISASSEMBLED. THE STENT RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). KINKS WERE OBSERVED IN THE STABILITY SHEATH (SS) AND SRS, 32CM, 70CM, 84CM, 90CM AND 104CM FROM THE DISTAL END OF THE SRS, WHICH COULD HAVE OCCURRED DUE TO THE IPSILATERAL APPROACH OR DURING TRANSPORT BACK TO COOK IRELAND. THERE WAS NO TACTILE DAMAGE OBSERVED ON THE SRS, BUT A SLIGHT CRINKLE WAS FOUND ON THE SRS, JUST DISTAL TO THE SRS/SS JOINT. NO PORTION OF THE STENT WAS RETURNED WITH THE DEVICE. FISH MOUTH DAMAGE WAS FOUND 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 (SRS). POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY, THE APPROACH USED AND THE USE OF A NON-RECOMMENDED WIRE GUIDE. THE HEAVILY CALCIFIED ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT. THE NON-RECOMMENDED DIAMETER OF WIRE GUIDE COULD HAVE PROVIDED INSUFFICIENT SUPPORT DURING DEPLOYMENT. THE USE OF A 125CM DEVICE IN AN IPSILATERAL APPROACH MEANT THAT THE STABILITY SHEATH WOULD NOT BE IN THE ACCESS SHEATH DURING DEPLOYMENT, POSSIBLY PROVIDING INSUFFICIENT SUPPORT OR STABILITY DURING DEPLOYMENT OR LEADING TO THE KINKS IN THE SHEATHS. THE PHYSICIAN WAS ALSO REPORTED TO HAVE HAD THEIR HAND ON THE SHEATHS DURING DEPLOYMENT, WHICH COULD HAVE RESULTED IN RESISTANCE DURING DEPLOYMENT. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH. 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¿ "ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH." 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 (SRS). THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED 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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # P100022/S001. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿". AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS WITH IMAGE REVIEW. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿". AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿". AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿". AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197877 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38486 | C1430075 | 10827002384863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |