ZILVER VENA VENOUS SELF EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00116
- Event Type
- Malfunction
- Date Received
- February 17, 2023
- Date of Event
- December 6, 2022
- Report Date
- April 26, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
COMMON NAME: QAN. 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 IS RELATED TO (B)(4) ( MDR REF. - 3001845648-2023-00117 ), (B)(4) ( MDR REF. - 3001845648-2023-00119), (B)(4) (MDR REF. - 3001845648-2023-00198) , (B)(4) (MDR REF. - 3001845648-2023-00197), AND (B)(4) (MDR REF. - 3001845648-2023-00196) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿HOFMANN 2022 LITERATURE PRELIMINARY REVIEW.MSG¿. THIS FILE CAPTURES THE POSSIBILITY THAT THE EVENT OCCURRED IN THE US, (B)(4) CAPTURES THE POSSIBILITY THAT THE EVENT OCCURRED IN TAIWAN. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS HOWEVER FROM THE INFORMATION PROVIDED THE DEVICE WAS DEPLOYED INTO THE INFERIOR VENA CAVA IN 04 CASES AND INTO A COLLATERAL VESSEL IN 01 CASE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER HOFMANN ET AL ¿12-MONTH ENDPOINT RESULTS FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT IN THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION¿. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THESE OCCURRENCES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COMMON NAME: QAN. PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CORRECTION FOR UPDATES MADE TO BRIEF DESCRIPTION, QTY AND EVENT DESCRIPTION. UPDATED EVENT DESCRIPTION BELOW: HOFMANN 2022 - 12- MONTH ENDPOINT RESULTS FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT IN THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY). TWO-VIEW VENOGRAPHY WAS PERFORMED TO ASSESS THE STUDY LESION CHARACTERISTICS (E.G., LOCATION, MINIMUM LUMEN DIAMETER [MLD]) AND TO ASSIST WITH STENT SIZING. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONSIDERED STANDARD OF CARE DURING STUDY DESIGN DEVELOPMENT AND WAS NOT REQUIRED PER THE PROTOCOL. MLD WAS DETERMINED USING TWO VENOGRAPHY PROJECTIONS, BASED ON DIAMETER MEASUREMENTS OF THE NARROWEST POINT IN THE TREATED SEGMENT OF VEIN (THE STENTED SEGMENT AND 1 CM ADDITIONAL CRANIAL AND CAUDAL TO THE STENT). VENOGRAPHIC MEASUREMENTS USED A CALIBRATION SOURCE (EITHER INTRAVASCULAR CALIBRATION DEVICE(S) OR AN EXTERNAL CALIBRATED DEVICE). PRE-DILATION OF THE VESSEL AND POST-STENT DILATATION WERE RECOMMENDED. STENTS WERE RECOMMENDED TO BE OVERSIZED BY 2-4 MM RELATIVE TO THE SURROUNDING VASCULATURE, THE EXPANDED BALLOON DIAMETER USED FOR PREDILATATION, OR THE STANDARD DIAMETER OF THE VEIN TO BE STENTED. STENTS WERE RECOMMENDED TO FULLY COVER THE LESION AND EXTEND INTO HEALTHY TISSUE (CAUDALLY AND CRANIALLY) BY 5-10 MM. WHEN MULTIPLE STENTS WERE REQUIRED, STENT OVERLAP BY AT LEAST 1 CM WAS RECOMMENDED. UPON PROCEDURE COMPLETION, TWO-VIEW VENOGRAPHY WAS USED TO EVALUATE THE LESION AND STENT PLACEMENT CHARACTERISTICS. TECHNICAL SUCCESS FAILURE: STENT DEPLOYED INTO THE IVC (N=4; THE STENT UNINTENTIONALLY COVERED THE IVC JUNCTION FOR 2 PLACEMENTS AND THE STENT WAS NOT PLACED IN THE EXACT INTENDED LOCATION FOR 2 PLACEMENTS) AND INTO AN UNINTENDED COLLATERAL VESSEL (N=1).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 26-APR-2023.
HOFMANN 2022 - 12- MONTH ENDPOINT RESULTS FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT IN THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY). TWO-VIEW VENOGRAPHY WAS PERFORMED TO ASSESS THE STUDY LESION CHARACTERISTICS (E.G., LOCATION, MINIMUM LUMEN DIAMETER [MLD]) AND TO ASSIST WITH STENT SIZING. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONSIDERED STANDARD OF CARE DURING STUDY DESIGN DEVELOPMENT AND WAS NOT REQUIRED PER THE PROTOCOL. MLD WAS DETERMINED USING TWO VENOGRAPHY PROJECTIONS, BASED ON DIAMETER MEASUREMENTS OF THE NARROWEST POINT IN THE TREATED SEGMENT OF VEIN (THE STENTED SEGMENT AND 1 CM ADDITIONAL CRANIAL AND CAUDAL TO THE STENT). VENOGRAPHIC MEASUREMENTS USED A CALIBRATION SOURCE (EITHER INTRAVASCULAR CALIBRATION DEVICE(S) OR AN EXTERNAL CALIBRATED DEVICE). PRE-DILATION OF THE VESSEL AND POST-STENT DILATATION WERE RECOMMENDED. STENTS WERE RECOMMENDED TO BE OVERSIZED BY 2-4 MM RELATIVE TO THE SURROUNDING VASCULATURE, THE EXPANDED BALLOON DIAMETER USED FOR PREDILATATION, OR THE STANDARD DIAMETER OF THE VEIN TO BE STENTED. STENTS WERE RECOMMENDED TO FULLY COVER THE LESION AND EXTEND INTO HEALTHY TISSUE (CAUDALLY AND CRANIALLY) BY 5-10 MM. WHEN MULTIPLE STENTS WERE REQUIRED, STENT OVERLAP BY AT LEAST 1 CM WAS RECOMMENDED. UPON PROCEDURE COMPLETION, TWO-VIEW VENOGRAPHY WAS USED TO EVALUATE THE LESION AND STENT PLACEMENT CHARACTERISTICS. TECHNICAL SUCCESS FAILURE: STENT DEPLOYED INTO THE IVC (N=4; THE STENT UNINTENTIONALLY COVERED THE IVC JUNCTION FOR 2 PLACEMENTS AND THE STENT WAS NOT PLACED IN THE EXACT INTENDED LOCATION FOR 2 PLACEMENTS). STENT DEPLOYED SHORT OF INTENDED TARGET LOCATION (N=1) OR INTO AN UNINTENDED COLLATERAL VESSEL (N=1), FORESHORTENING (N=2), MIGRATION (N=2; MINOR STENT MOVEMENT DURING PLACEMENT AND NOT RESULTING IN REINTERVENTION). 243 PATIENTS. AVERAGE AGE: 53 YEARS. GENDER: FEMALE 170, MALE 73.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134360 | ZILVER VENA VENOUS SELF EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female |