ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00076
- Event Type
- Malfunction
- Date Received
- February 3, 2023
- Date of Event
- January 9, 2023
- Report Date
- May 16, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- UDI-DI
- 10827002574516
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COMMON NAME - QAN. PRODUCT CODE - QAN. PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P200023. DEVICE EVALUATION: THE ZVT7-35-120-14-100 DEVICE OF LOT NUMBER C1852093 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 23 MARCH 2023. REFER TO THE RETURNED PRODUCT-NOTES FIELD FOR LAB EVALUATION NOTES AND ATTENDANCE. THE RETURNED DEVICE LAB EXAMINATION FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH ATTACHED PHOTOS. ON EVALUATION OF THE DEVICE THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION: RED SAFETY TAB NOT RETURNED. BROKEN SECTION OF THE STENT RETURNED SEPARATELY. ACCESS SHEATH ATTACHED TO OUTER CATHETER OF THE DEVICE. STENT PARTIALLY DEPLOYED AT ACCESS SHEATH. FUNCTIONAL INSPECTION: ACCESS SHEATH REMOVED FROM DEVICE CATHETER, STENT DEPLOYED ON REMOVAL. KINK OBSERVED ON THE INNER CATHETER APPROXIMATELY 8CM FROM WHITE TIP. DEVICE FLUSHED WITH NO ISSUE. WIRE GUIDE WOULD NOT PASS THE KINK ON THE INNER CATHETER. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: ¿IF EXCESSIVE RESISTANCE IS FELT WHEN BEGINNING DEPLOYMENT, DO NOT FORCE DEPLOYMENT. REMOVE THE DELIVERY SYSTEM WITHOUT DEPLOYING THE STENT AND REPLACE WITH A NEW DEVICE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE COULD NOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE PRESSURE PLACED ON THE DEVICE FROM DIFFICULT PATIENT ANATOMY WHICH MAY HAVE CAUSED THE KINK ON THE INNER CATHETER AS OBSERVED IN THE LAB EVALUATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE TARGET VESSEL WAS FIBROTIC AND A CHRONIC OBSTRUCTION WAS BEING TREATED. IT WAS ALSO NOTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION. AS A RESULT OF THE KINK ON THE INNER CATHETER, THE OUTER SHEATH COULD NOT BE FULLY WITHDRAWN OVER THE INNER CATHETER TO DEPLOY THE STENT, THE STENT COULD ONLY BE PARTIALLY DEPLOYED. THE DEVICE WITH PARTIALLY DEPLOYED STENT WAS WITHDRAWN TO THE ACCESS SHEATH AND REMOVED FROM THE BODY. PART OF THE STENT THAT HAD BEEN PARTIALLY DEPLOYED BROKE OFF DURING REMOVAL HOWEVER THIS WAS ALSO RETRIEVED SUCCESSFULLY. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON VISUAL AND FUNCTIONAL INSPECTION. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, DURING THE PLACEMENT OF 01 ZVT7 DEVICE IN THE ILIAC/FEMORAL VEIN, THE STENT WAS DEPLOYED 10MM AND THEN IT GOT STUCK AND NEEDED TO BE REMOVED FROM THE PATIENT. DURING REMOVAL OF THE DEVICE, PART OF THE STENT THAT HAD BEEN PARTIALLY DEPLOYED BROKE OFF, THIS WAS RETRIEVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL DEVICE, WITHIN THE SAME OPERATING PROCEDURE. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE PRESSURE FROM DIFFICULT PATIENT ANATOMY WHICH CAUSED A KINK ON THE INNER CATHETER OF THE DEVICE, AS OBSERVED IN THE LAB EVALUATION. AS A RESULT OF THE KINK, THE STENT COULD ONLY BE PARTIALLY DEPLOYED. THE COMPLAINT IS CONFIRMED BASED ON VISUAL AND FUNCTIONAL INSPECTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE COMPLAINT DEVICE.
AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE DEVICE WAS IN PLACE OVER AN AMPLATZ WIRE. HOWEVER, THE PHYSICIAN WENT TO DEPLOY IT AND IT WAS VERY STIFF. THE PHYSICIAN WAS ABLE TO DEPLOY ABOUT 10MM OF STENT AND IT STUCK. THEREFORE, IT COULD NOT BE DEPLOYED. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AS FAR AS HE COULD TO THE SHEATH, AND REMOVED THE SHEATH. THE STENT DID GET CAUGHT IN THE FASCIA. THE STENT FRACTURED AND SEPARATE; HOWEVER THE PHYSICIAN WAS ABLE TO GET IT OUT SUCCESSFULLY. AT THIS POINT, A NEW WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. NOTE: THERE WERE NOT ADVERSE EVENTS REPORTED TO THE DM. PATIENT OUTCOME : DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. N/A. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. N/A. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. N/A. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NONE REPORTED TO THE DM. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NONE REPORTED TO THE DM. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. N/A. PATIENT/EVENT INFO NOTES: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? - CHRONIC DVT AND ILIO FEMORAL VEIN OBSTRUCTION. IF YES, PLEASE SPECIFY: SEE ABOVE. PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) FIBROTIC. IF OTHER, PLEASE SPECIFY: N/A. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? DM BELIEVES IT WAS THE SAPHENOUS VEIN. WAS THE ACCESS SITE JUGULAR OR FEMORAL?GREATER SAPHENOUS VEIN. IF OTHER, PLEASE SPECIFY: N/A. WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? CHRONIC OBSTRUCTION. IF OTHER, PLEASE SPECIFY .N/A. WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? IPSILATERAL. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? NO. WHAT WAS THE TARGET LOCATION FOR THE STENT? - EXTERNAL ILIAC AND FEMORAL VEIN DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 7FR TERUMO. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? - YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? AMPLATZ.. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? YES. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO. IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? N/A. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? N/A. DID THE USER PUSH THE HUB DURING DEPLOYMENT? NO. DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? YES. WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? NO. WAS THE STENT FULLY DEPLOYED IN THE PATIENT? NO. WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? NO. WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES. WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A. PLEASE SPECIFY IF YES. N/A.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 16-MAY-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 988134 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | G57451 | C1852093 | 10827002574516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |