ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00766
- Event Type
- Malfunction
- Date Received
- October 28, 2021
- Date of Event
- October 1, 2021
- Report Date
- September 30, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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. DEVICE EVALUATION: THE ZVT7-35-120-16-100 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 5TH OF NOVEMBER, 2021 . ON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE OUTER SHEATH SEPARATED FROM THE HANDLE, 2CM FROM THE WHITE CONNECTOR CAP. THE DEVICE FLUSHED AS EXPECTED. A 0.035 INCH WIRE GUIDE PASSED WITH SLIGHT RESISTANCE AT THE DAMAGED AREA. THE STENT WAS NOT RETURNED. PLEASE NOTE THAT TWO IMAGES WERE SENT DIGITALLY TO CIRL PRIOR TO DEVICE RETURN. THE TWO IMAGES SHOW THAT THE OUTER SHEATH SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE SAME DEFECT WAS ALSO CONFIRMED ON THE ZVT7 DEVICE IN THE LAB AT CIRL. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZVT7-35-120-16-100 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 THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. (IFU0091-8). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO COMPRESSION ON THE DEVICE CAUSED BY DIFFICULT PATIENT ANATOMY, AS IT IS KNOWN THAT THE PATIENT HAD SIGNIFICANT COMPRESSION FROM THE ARTERY OVER LAYING THE VEIN. ANOTHER POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO THE ANGLE AT WHICH THE USER HELD THE DEVICE DURING DEPLOYMENT. IT IS KNOWN THAT THE USER MAY HAVE HELD THE DEVICE AT A LOWER ANGLE, WHICH COULD HAVE ADDED FURTHER COMPRESSION TO THE DEVICE, CAUSING THE CATHETER TO BREAK AWAY FROM THE HANDLE AT THE CONNECTOR CAP. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS 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.
PMA/510(K) #: P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL MDR BEING SUBMITTED DUE TO COMPLETION OF LAB EVALUATION ON 05-NOV-2021: LAB EVALUATION COMPLETED ON 05-NOV-21: OUTER SHEATH SEPARATED FROM HANDLE.
SUPPLEMENTAL MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 30 - SEPT - 2022.
THE DELIVERY CATHETER SHEATH FOR ZILVER VENA STRETCHED AWAY FROM THE HUB OF THE BLACK PIN AND PULL SYSTEM. I HAVE ATTACHED PICTURES OF THE PRODUCT. THE PATIENT HAD SIGNIFICANT COMPRESSION FROM THE ARTERY OVER LAYING THE VEIN. THEY USED A .035 WIRE TO STENT THE LEFT COMMON ILIAC VEIN WITH A 16X100 ZILVER VENA STENT. AS HE WAS DEPLOYING THE STENT HE HAD A LOT OF PRESSURE ON THE CATHETER AT A DOWNWARD ANGLE WHICH CAUSED THE SHEATH COILING TO STRETCH AWAY FROM THE HUB. THERE WERE NO ADDITIONAL ISSUES WITH ANY OF THE PRODUCTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL PROCEDURES/INTERVENTIONS REQUIRED FOR THE PATIENT. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES 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. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO. THE FOLLOWING HAS BEEN REQUESTED AND ANSWERED- (B)(6) 12OCT2021 PREFIX ZVT7 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO YES. 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO NO. ¿ IF YES, PLEASE SPECIFY: 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? NO WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER CALCIFIED ¿ IF OTHER, PLEASE SPECIFY: 3.94 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO NO. 3.95 WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO YES. 3.96 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? 3.97 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER LEFT COMMON FEMORAL VEIN. ¿ IF OTHER, PLEASE SPECIFY: 3.98 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? ¿ IF OTHER, PLEASE SPECIFY 3.99 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL IPSILATERAL 3.100 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO YES 3.101 WHAT WAS THE TARGET LOCATION FOR THE STENT? LEFT COMMON ILIAC 3.102 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 8 FRENCH 10 CM 3.103 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO YES. 3.104 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? 035 GLIDEWIRE NOT HYDROPHILIC 3.105 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? N/A, YES, NO NO. 3.106 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? N/A, YES, NO NO. 3.107 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.108 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? N/A, YES, NO YES. 3.109 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? N/A, YES, NO YES. 3.110 DID THE USER PUSH THE HUB DURING DEPLOYMENT? N/A, YES, NO NO. 3.111 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? N/A, YES, NO YES. 3.112 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? N/A, YES, NO NO. 3.113 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? N/A, YES, NO YES. 3.114 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? N/A, YES, NO YES. 3.115 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO YES 3.116 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? N/A, YES, NO YES. 3.117 WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A. 3.118 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY N/A. 3.119 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO NO. ¿ PLEASE SPECIFY IF YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1614545 | ZILVER VENA VENOUS SELF-EXPANDING STENT | Stent, iliac vein | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |