ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00588
- Event Type
- Malfunction
- Date Received
- July 29, 2021
- Date of Event
- July 1, 2021
- Report Date
- September 27, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) #: P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #: P200023. PRODUCT CODE: QAN. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. INCIDENT DOES NOT MEET THE CRITERIA AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. THIS COMPLAINT IS CREATED TO CAPTURE NEGATIVE FEEDBACK. THE ZVT7-35-80-12-140 DEVICE OF UNKNOWN LOT NUMBER 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. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 19TH AUGUST 2021. ON EVALUATION OF THE DEVICE, NO DEFECT ON THE DEVICE WAS OBSERVED. THE 04 GOLD MARKERS WERE VISIBLE ON THE STENT. THE DEVICE FLUSHED AS EXPECTED AND A 0.035 INCH WIRE GUIDE PASSED THE DEVICE WITHOUT ISSUES. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE ZVT7-35-80-12-140 DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZVT7-35-80-12-140 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ARE IFU0091-7. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS NO DEFECT COULD BE OBSERVED AND THE DEVICE FUNCTIONED AS EXPECTED DURING THE LAB EVALUATION AT CIRL. COMPLAINT IS NOT CONFIRMED AS THE FAILURE COULD NOT BE VERIFIED IN THE LABORATORY. 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.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF THE COMPLAINT DEVICE AND DEVICE EVALUATION, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO CAPTURE THIS.
CANCELLATION REPORT: INCIDENT DOES NOT MEET THE CRITERIA AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. THIS COMPLAINT IS CREATED TO CAPTURE NEGATIVE FEEDBACK.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: P200023. PRODUCT CODE: QAN.
"THE DISTAL END OF THE STENT DID NOT HAVE RADIOPAQUE MARKERS. A NEW STENT (UNKNOWN COOK MODEL)." PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1147392 | ZILVER VENA VENOUS SELF-EXPANDING STENT | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |