ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2021-00890
- Event Type
- Malfunction
- Date Received
- December 23, 2021
- Report Date
- February 23, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002353135
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # P100022/S014. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P100022/S014. DEVICE EVALUATION 1 UNIT OF ZISV6-35-80-7.0-60-PTX LOT# C1756432 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. 3 ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS DEVICE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. IF ADDITIONAL INFO IS RECEIVED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 24 JAN 2022. ON EVALUATION OF THE DEVICE THERE WAS NO VISUAL DEFECTS/DAMAGE OBSERVED. SAFETY LOCK WAS DEPRESSED. WIRE GUIDE INTRODUCED THROUGH DEVICE WITH NO ISSUE. DEVICE FLUSHED WITH NO ISSUES OBSERVED. THUMBWHEEL ROTATED FREELY BUT STENT COULD NOT BE DEPLOYED. HANDLE OPENED AND RETRACTION WIRE HAS SEPARATED FROM THE STENT RETRACTION SHEATH. DOCUMENTS REVIEW INCLUDING IFU REVIEW PRIOR TO DISTRIBUTION ZISV6-35-80-7.0-60-PTX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL A REVIEW OF THE MANUFACTURING RECORDS FOR ZISV6-35-80-7.0-60-PTX OF LOT NUMBER C1756432 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT 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 C1756432. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0117-5) STATES THE FOLLOWING: ¿DO NOT USE EXCESSIVE FORCE TO DEPLOY THE STENT. IF EXCESSIVE RESISTANCE IS FELT WHEN BEGINNING DEPLOYMENT, REMOVE THE DELIVERY SYSTEM WITHOUT DEPLOYING THE STENT AND REPLACE WITH A NEW DEVICE¿. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW N/A . ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. CAPA WAS PREVIOUSLY OPENED TO DOCUMENT THE ACTIONS TAKEN TO IMPROVE THE STRENGTH OF THE STENT RETRACTION WIRE/STENT RETRACTION SHEATH JOINT. HISTORICALLY INCORRECT SIZED WIREGUIDES AND DIFFICULT PATIENT ANATOMY HAVE BEEN MOST COMMONLY ASSOCIATED WITH RETRACTION WIRE SEPARATION FROM STENT RETRACTION SHEATH COMPLAINTS. HOWEVER IN THIS CASE THE DOCTOR NOTED "IT WAS A STRAIGHT FORWARD CASE; NO TORTUOUS ANATOMY OR CALCIFICATION¿ AND A 0.035" GUIDEWIRE WAS USED. NO ROOT CAUSE HAS BEEN IDENTIFIED THROUGH CAPA TO DATE. THIS DEVICE WAS MANUFACTURED USING THE OLDER SRS DESIGN WHICH IS NOW BEING PHASED OUT AND REPLACED WITH THE NEWER SRS DESIGN. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IF ADDITIONAL INFO IS RECEIVED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # P100022/S014. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
STENT WOULDN'T DEPLOY- AWAITING MORE DETAILS. PATIENT OUTCOME: TBA.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE LAB EVALUATION DATE: 24 JAN 2022 AND UPDATED EVENT DESCRIPTION 08-FEB-2022. VISUAL INSPECTION: NO ISSUES OBSERVED. SAFETY LOCK DEPRESSED FUNCTIONAL INSPECTION: WIRE GUIDE INTRODUCED THROUGH DEVICE WITH NO ISSUE. DEVICE FLUSHED WITH NO ISSUES OBSERVED. NO DAMAGE/DEFECTS OBSERVED. THUMBWHEEL ROTATED FREELY BUT STENT COULD NOT BE DEPLOYED. HANDLE OPENED AND RETRACTION WIRE HAS SEPARATED FROM THE STENT RETRACTION SHEATH. UPDATE TO PRECEDENCE BELOW. NO ISSUE WITH THUMBWHEEL. RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH BEING APPLIED. FOLLOW UP MDR SCHEDULED TO CAPTURE LAB. UPDATES TO THE EVENT DESCRIPTION: UPDATES FROM THE DOCTOR RECEIVED ON 8/2/2022 JIL01: THE REP SPOKE WITH DR (B)(6)- HE VAGUELY REMEMBERS AS IT WAS A LONG TIME AGO- UNSURE OF DATE OR PATIENT. HE SAID IT WAS ODD BECAUSE IT WAS A STRAIGHT FORWARD CASE NO TORTUOUS ANATOMY OR CALCIFICATION. HE WENT TO DEPLOY AND THE THUMB WHEEL BROKE IMMEDIATELY- HEARD A CLICK AND IT STARTED SPINNING FREELY. NON OF THE STENT HAD PARTIALLY DEPLOYED SO HE REMOVED AND USED ANOTHER PTX IN SAME SIZE. HE SAID THAT IF IT IS CALCIFIED OR TORTUOUS ANATOMY AND IF THE STENT DOES PARTIALLY DEPLOY AND THUMB WHEEL BREAKS HE CAN TAKE IT APART AND DEPLOY LIKE A PIN AND PULL TO COMPLETE STENT DEPLOYMENT BUT IT HADN'T HAPPENED LIKE THAT. USED A GLIDE WIRE ADVANTAGE BRAIDED 035". NEXT STENT DEPLOYED FINE AND PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1980472 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | C1756432 | 10827002353135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |