ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00280
- Event Type
- Malfunction
- Date Received
- June 21, 2018
- Date of Event
- May 23, 2018
- Report Date
- August 16, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA #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 PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
PMA #P100022/S014. 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). PROBLEM STATEMENT "AS REPORTED TO CUSTOMER RELATIONS: "UPON DELIVERY OF THE STENT, THE DISTAL TIP FRACTURED AND CAME COMPLETELY APART. NOTHING LEFT IN PATIENT. PROCEDURE INVOLVED PLACING TWO 6X140S AND ONE 6X80--ANOTHER DEVICE WAS OPENED FOR THE COMPLAINT DEVICE, AND THESE THREE WORKED SUCCESSFULLY.¿ ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 14AUG2018: "THE COMPLAINT FROM DR. (B)(6) CASE IS CONSIDERED A REPORTABLE EVENT AND THE INVESTIGATION TEAM HAS SOME ADDITIONAL QUESTIONS. IT HAS BEEN A LITTLE WHILE AGO SO I WANTED TO REACH OUT TO CONFIRM THE DETAILS PRIOR TO RESPONDING TO THEIR REQUEST. COULD YOU CONFIRM IF THE PTX (G38483, LOT # C1463524) WAS IMPLANTED IN DR. (B)(6) PATIENT ON (B)(6)? WERE ANY OF THE DEVICES STUCK ON THE WIRE GUIDE DURING THE PROCEDURE? IF SO, DID IT RESULT IN ANY OF THE PRODUCTS NOT BEING ABLE TO BE DEPLOYED. ADDITIONALLY, COULD YOU PROVIDE PRODUCT G# AND LOT# FOR THE OTHER PRODUCTS THAT WERE IMPLANTED ON (B)(6)? ----- YES, PTX G38483 LOT# C1463524 WAS IMPLANTED. IN FACT, 3 OF THE SAME SIZE AND LOT# WERE IMPLANTED. THREE 6X140 STENTS WITH SAME LOT#. THE FOURTH STENT WAS G38480 LOT# C1480754.¿ ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2018: "I CAN CONFIRM THAT NONE OF THE FOUR STENTS IMPLANTED DEPLOYED AT THE LENGTH DENOTED ON THE PACKAGING. THE DIFFICULTY WAS THAT THE CUSTOMER WAS PLACING THE PTX IN THE PATIENT THROUGH AN OPEN ACCESS, THERE WAS NO SHEATH UTILIZED. THE CUSTOMER DID NOT HOLD TENSION ON THE DEPLOYMENT SYSTEM ABOVE THE TRANSITION POINT AT THE RETRACTION PORTION OF THE DEPLOYMENT SYSTEM. THE RESULT WAS THE DEVICE DROVE FORWARD AND TELESCOPED THE STENTS. ALL FOUR IMPLANTED STENTS DEPLOYED AT FORESHORTENED LENGTHS RESULTING IN THE PHYSICIAN PLACING 4 STENTS IN THE PATIENT WHEN HE COULD HAVE TREATED WITH 3 IF THE STENTS HAD NOT FORESHORTENED. AFTER BEING NOTIFIED OF THIS EVENT, WE RE-EDUCATED THE PHYSICIAN AND STAFF REGARDING THE BEST TECHNIQUE TO UTILIZE WHEN DEPLOYING PTX THROUGH AN OPEN ACCESS. I HOPE THIS HELPS. PLEASE LET ME KNOW IF YOU HAVE ANY ADDITIONAL QUESTIONS." ADDITIONAL INFORMATION PROVIDED ON 14AUG2018: "I HAVE CONFIRMED WITH THE ACCOUNT THAT NONE OF THE STENTS FRACTURED OR CAME APART." DEVICE EVALUATION THE ZISV6-35-125-6-140-PTX DEVICE OF LOT NUMBER C1463524 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE INVESTIGATION WILL BE UPDATED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED. THERE ARE THREE COMPLAINTS RELATED TO THIS DEVICE. THIS COMPLAINT DETAILS THE INVESTIGATION FOR THE FRACTURE OF THE DISTAL TIP. A GUIDE STIFF ANGLE 0.035¿ WIRE GUIDE WAS USED DURING THE PROCEDURE. THE DEVICE WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU). FROM CUSTOMER TESTIMONY, IT WAS CONFIRMED THAT THE TARGET SITE WAS SEVERELY CALCIFIED/TORTUOUS. THE PATIENT¿S LEG WAS CONFIRMED TO HAVE A LOT OF PROBLEMS AND WAS DESCRIBED AS A ¿DISASTER¿. IT IS KNOWN THAT THREE PTX STENTS (G38483, LOT# C1463524) OF THE SAME SIZE (6X140) AND LOT NUMBER WERE IMPLANTED IN THE PATIENT. A FOURTH STENT (G38480, LOT# C1480754) WAS ALSO IMPLANTED. FROM CUSTOMER TESTIMONY IT IS KNOWN THAT THE USER FAILED TO USE AN ACCESS SHEATH DURING THE COMPLAINT PROCEDURE. THE DEVICE RELATED TO THIS COMPLAINT UNDERWENT A LABORATORY EVALUATION ON THE 14 JUNE 2018 AND THE 09 AUGUST 2018. ON EVALUATION OF THE RETURNED DEVICE, THE DISTAL WHITE TIP AND THE DISTAL INNER WERE DETACHED. THE STENT WAS NOT RETURNED. NO TACTILE DAMAGE WAS NOTED ON THE STENT RETRACTION SHEATH (SRS). 19.2 CM OF THE DISTAL INNER WAS DETACHED (FROM THE END OF THE WHITE TIP). A 0.035¿ WIRE GUIDE WAS ADVANCED THROUGH THE DEVICE (HANDLE AND DETACHED PORTION) WITH NO ISSUES. THE DEVICE HANDLE WAS OPENED AND THE SRS AND THE WIRE WERE FULLY ATTACHED. NO DAMAGE WAS NOTED ON THE PROXIMAL INNER A SECOND LAB EVALUATION WAS CONDUCTED ON THE (B)(6) 2018. THIS WAS TO EXAMINE THE LASER CUT HOLES ON THE DEVICE TO DETERMINE WHERE THE BREAKAGE IN THE DEVICE OCCURRED. THE LASER CUT HOLE AT THE BREAK IN THE DEVICE WAS MEASURED AT 0.12 MM. THE LASER CUT ALONG THE LENGTH MEASURED 0.097 MM. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE DISTAL TIP WAS DETACHED. POSSIBLE ROOT CAUSES FOR THIS COMPLAINT COULD INCLUDE DIFFICULT PATIENT ANATOMY AND NOT USING AN ACCESS SHEATH. THE CALCIFIED/TORTUOUS PATIENT ANATOMY COULD HAVE CAUSED OF CONTRIBUTED TO THE FRACTURE OF THE DISTAL WHITE TIP. IT IS POSSIBLE THAT RESISTANCE (DUE TO DIFFICULT PATIENT ANATOMY) DURING ADVANCEMENT AND/OR DEPLOYMENT COULD HAVE CAUSED OR CONTRIBUTED TO THE FRACTURE IN THE DISTAL TIP. NOT USING AN ACCESS SHEATH WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO INSTABILITY OF THE DEVICE DURING ADVANCEMENT AND/OR DEPLOYMENT. IT IS POSSIBLE THAT THIS INSTABILITY CAUSED OR CONTRIBUTED THE FRACTURE OF THE WHITE TIP. FROM CUSTOMER TESTIMONY ¿THE DIFFICULTY WAS THAT THE CUSTOMER WAS PLACING THE PTX IN THE PATIENT THROUGH AN OPEN ACCESS, THERE WAS NO SHEATH UTILIZED. THE CUSTOMER DID NOT HOLD TENSION ON THE DEPLOYMENT SYSTEM ABOVE THE TRANSITION POINT AT THE RETRACTION PORTION OF THE DEPLOYMENT SYSTEM. THE RESULT WAS THE DEVICE DROVE FORWARD AND TELESCOPED THE STENTS¿ HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU0118-3) STATES THE FOLLOWING; ¿ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH.¿ DOCUMENT REVIEW 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 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 C1463524 SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE DISTAL TIP WAS DETACHED. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA #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). INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
PMA #P100022/S014. 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). INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT" AND "DELIVERY SYSTEM CANNOT BE WITHDRAWN". AS REPORTED TO CUSTOMER RELATIONS: "UPON DELIVERY OF THE STENT, THE DISTAL TIP FRACTURED AND CAME COMPLETELY APART. NOTHING LEFT IN PATIENT. PROCEDURE INVOLVED PLACING TWO 6X140S AND ONE 6X80--ANOTHER DEVICE WAS OPENED FOR THE COMPLAINT DEVICE, AND THESE THREE WORKED SUCCESSFULLY.
REPORT IS BEING SUBMITTED BASED ON THE SEPARATION OF THE DISTAL INNER. THE DIFFICULTY WAS THAT THE CUSTOMER WAS PLACING THE PTX IN THE PATIENT THROUGH AN OPEN ACCESS, THERE WAS NO SHEATH UTILIZED. THE CUSTOMER DID NOT HOLD TENSION ON THE DEPLOYMENT SYSTEM ABOVE THE TRANSITION POINT AT THE RETRACTION PORTION OF THE DEPLOYMENT SYSTEM. THE RESULT WAS THE DEVICE DROVE FORWARD AND TELESCOPED THE STENTS. ON WITHDRAWAL THE DISTAL INNER SEPARATED. ALL FOUR IMPLANTED STENTS DEPLOYED AT FORESHORTENED LENGTHS RESULTING IN THE PHYSICIAN PLACING 4 STENTS IN THE PATIENT WHEN HE COULD HAVE TREATED WITH 3 IF THE STENTS HAD NOT FORESHORTENED.
THIS FOLLOW UP MDR 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: ¿DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT" AND "DELIVERY SYSTEM CANNOT BE WITHDRAWN". AS REPORTED TO CUSTOMER RELATIONS: "UPON DELIVERY OF THE STENT, THE DISTAL TIP FRACTURED AND CAME COMPLETELY APART. NOTHING LEFT IN PATIENT. PROCEDURE INVOLVED PLACING TWO 6X140S AND ONE 6X80--ANOTHER DEVICE WAS OPENED FOR THE COMPLAINT DEVICE, AND THESE THREE WORKED SUCCESSFULLY.
REPORT IS BEING SUBMITTED BASED ON THE SEPARATION OF THE DISTAL INNER. THE DIFFICULTY WAS THAT THE CUSTOMER WAS PLACING THE PTX IN THE PATIENT THROUGH AN OPEN ACCESS, THERE WAS NO SHEATH UTILIZED. THE CUSTOMER DID NOT HOLD TENSION ON THE DEPLOYMENT SYSTEM ABOVE THE TRANSITION POINT AT THE RETRACTION PORTION OF THE DEPLOYMENT SYSTEM. THE RESULT WAS THE DEVICE DROVE FORWARD AND TELESCOPED THE STENTS. ON WITHDRAWAL THE DISTAL INNER SEPARATED. ALL FOUR IMPLANTED STENTS DEPLOYED AT FORESHORTENED LENGTHS RESULTING IN THE PHYSICIAN PLACING 4 STENTS IN THE PATIENT WHEN HE COULD HAVE TREATED WITH 3 IF THE STENTS HAD NOT FORESHORTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467612 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38483 | C1463524 | 10827002384832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |