ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2024-00237
- Event Type
- Injury
- Date Received
- May 28, 2024
- Date of Event
- May 5, 2023
- Report Date
- November 6, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- PMA / PMN Number
- P200023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, HK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P200023. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE CREATED FROM THE JOURNAL ARTICLE TAN ET AL 2023 ¿PROCEDURAL AND CLINICAL OUTCOMES OF DEDICATED VENOUS STENTS IN ACUTE AND PROCEDURAL AND CLINICAL OUTCOMES OF DEDICATED VENOUS STENTS IN ACUTE AND CHRONIC VENOUS OBSTRUCTION: A RETROSPECTIVE SINGLE CENTER STUDY CHRONIC VENOUS OBSTRUCTION: A RETROSPECTIVE SINGLE CENTER¿. THIS COMPLAINT CAPTURES (B)(4) CASES OF LOSS OF PATENCY. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE FOR LOSS OF PATENCY COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. PRE-EXISTING CONDITIONS INCLUDED RISK FACTORS FOR THROMBOSIS OR OCCLUSION INCLUDING CURRENT MALIGNANCY, SMOKING, HISTORY OF THROMBOPHILIA, HISTORY OF VENOUS THROMBOEMBOLISM AND POST-THROMBOTIC SYNDROME. AS PREVIOUSLY MENTIONED, THE IFU LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS FILE WAS CREATED FROM JOURNAL ARTICLE TAN ET AL 2023 ¿PROCEDURAL AND CLINICAL OUTCOMES OF DEDICATED VENOUS STENTS IN ACUTE AND PROCEDURAL AND CLINICAL OUTCOMES OF DEDICATED VENOUS STENTS IN ACUTE AND CHRONIC VENOUS OBSTRUCTION: A RETROSPECTIVE SINGLE CENTER STUDY CHRONIC VENOUS OBSTRUCTION: A RETROSPECTIVE SINGLE CENTER¿. CONFIRMED QUANTITY OF (B)(4) DEVICES, CONFIRMED USED. AS PER MEDICAL ADVISOR INPUT, SEVERITY OF (B)(4) CAN BE ASSIGNED AS LOSS OF PATENCY DOES NOT ALWAYS GUARANTEE A REINTERVENTION, NO EVIDENCE IN THE ARTICLE SHOWED A TREATMENT OR INTERVENTION. INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. AS PREVIOUSLY NOTED, RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN ARE KNOWN POTENTIAL ADVERSE EVENTS.
DESCRIPTION OF EVENT: GUANG M. TAN, 2023 ¿ PROCEDURAL AND CLINICAL OUTCOMES OF DEDICATED VENOUS STENTS IN ACUTE AND CHRONIC VENOUS OBSTRUCTION: A RETROSPECTIVE SINGLE CENTER STUDY THE SIZE AND THE TOTAL LENGTH OF STENTS REQUIRED WOULD BE DETERMINED EITHER BY IVUS OR BY ANGIOGRAPHY. THE DIAMETER OF STENT WOULD BE CHOSEN TO BE 1 SIZE ABOVE THE SIZE REQUIRED. FOR EXAMPLE, IF THE DIAMETER OF THE TARGET SEGMENT WAS MEASURED TO BE 14 MM, A 16 MM STENT WOULD BE USED. THE TOTAL LENGTH OF THE STENTS REQUIRED WOULD BE CHOSEN TO BE 20 MM MORE THAN THE LENGTH REQUIRED, WITH 10 MM ADDED TO THE PROXIMAL AND THE DISTAL ENDS. FOR EXAMPLE, IF THE TOTAL LENGTH REQUIRED WAS MEASURED TO BE 100 MM, A 120 MM STENT WOULD BE USED. AFTER VENOUS STENT IMPLANTATION, POST-DILATATION WOULD BE PERFORMED USING BALLOON APPROXIMATING TO THE VESSELS SIZE. DEDICATED VENOUS STENTS FROM 4 DIFFERENT MANUFACTURERS (ZILVER VENA; COOK, DUBLIN, IRELAND. VICI; BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA; VENOVO; BARD INC, TEMPE, AZ, USA. ABRE; MEDTRONIC, MINNEAPOLIS, MN, USA.) WERE USED BY RANDOM ROTATIONS. LOSS OF PATENCY: 90-DAY PRIMARY PATENCY RATE WAS 90.2%. THE PRIMARY EFFICACY ENDPOINT IS THE 90-DAY PRIMARY PATENCY WHICH IS DEFINED AS A PATENT VEIN WITHOUT RECURRENT STENOSIS OR THE NEED FOR REPEAT INTERVENTION WITHIN THE VEINS. PATIENT OUTCOME: NOT SUPPLIED IN THE ARTICLE. PATIENT/EVENT INFO - NOTES: 41 PATIENTS WITH MEDIAN AGE OF 60. 18 MALES: 23 FEMALES.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 05-SEP-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624220 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |