ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00727
- Event Type
- Malfunction
- Date Received
- October 13, 2021
- Date of Event
- September 15, 2021
- Report Date
- January 28, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- UDI-DI
- 10827002574493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
COMMON NAME - QAN PRODUCT CODE - QAN PMA/510(K) # P200023. DEVICE EVALUATION THE ZVT7-35-80-16-140 DEVICE OF LOT NUMBER C1847298 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZVT7-35-80-16-140 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZVT7-35-80-16-140 OF LOT NUMBER C1847298 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1847298. 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. IMAGE REVIEW IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. IMPRESSION 1. THE COMPLAINT OF STENT FORESHORTENING INDEPENDENT OF THE ANATOMY IS NOT CONFIRMED. GIVEN POSSIBLE 3% SHORTENING (4.2MM), THE MEASURED LENGTH OF THE STENT WAS 10.96MM (136.8MM-125.84MM) SHORTER THAN ITS DESIGNATED LENGTH. THE STRAIGHTER COURSE OF THE IVUS CATHETER UNDERESTIMATED THE STENT LENGTH MEDIAL TO LATERAL BY 4.74MM. THE AP STENT CURVATURE RELATIVE OF THE IVUS WOULD BE EVEN GREATER. BECAUSE AP PROJECTION COULD NOT DEPICT CURVATURE IN THE AP PROJECTION, AT LEAST 4.74MM OF AP LENGTH WAS UNACCOUNTED FOR. CONSEQUENTLY, THE STENT LENGTH INCLUDED ON THE EXAM WAS AT LEAST 135.32MM (125.84MM+(2(4.74MM))). BECAUSE THE SUPERIOR STENT END WAS LIKELY AT LEAST A FEW MILLIMETERS OFF THE IMAGE, THE STENT LENGTH WAS VERY LIKELY WITHIN ITS DESIGNATED LENGTH (135.22MM+STENT OFF IMAGE = 136.8MM). 2. IMPLANTATION OF THE STENT 2CM ABOVE ITS INTENDED DISTAL COVERAGE WAS THE RESULT IMPLANTATION SLIGHTLY ABOVE THE TARGET, FAILURE TO ACCOUNT FOR GREATER STENT TORTUOSITY RELATIVE TO THE IVUS, AND FAILURE TO ACCOUNT FOR 3% MAXIMUM STENT SHORTENING. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. THE ANATOMY OF THE PATIENT HAS BEEN DESCRIBED AS ¿FIBROTIC¿. THIS FIBROTIC STATE OF THE VESSEL MAY HAVE COMPRESSED THE STENT, WHICH MAY HAVE LED TO STENT FORESHORTENING. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT COULD NOT BE CONFIRMED BASED ON THE IMAGE REVIEW AS AN INCOMPLETE IMAGE OF THE STENT WAS SUPPLIED I.E THE SUPERIOR END OF THE STENT WAS NOT SHOWN IN THE IMAGE. 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 # - P200023 & COMMON NAME - QAN. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA # - P200023 & COMMON NAME - QAN. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
SUPPLEMENTAL REPORT AS DESCRIPTION OF EVENT UPDATED BELOW ON 10-OCT-21 DUE TO COMPLETION OF IMAGING REVIEW: "INTERVENTION REQUIRING A 16X140 ZILVER VENA STENT. AFTER DEPLOYMENT OF STENT AND 140MM WERE MEASURED USING THE IVUS CATHETER THE STENT FORESHORTENED ALMOST 2CM. AS PER IMAGING REVEIW ON 10-OCT-21: "THE SUPERIOR END OF THE STENT IS NOT DEFINITELY INCLUDED ON THE IMAGE. THE COMPLAINT OF STENT FORESHORTENING INDEPENDENT OF THE ANATOMY IS NOT CONFIRMED."
"INTERVENTION REQUIRING A 16X140 ZILVER VENA STENT. AFTER DEPLOYMENT OF STENT AND 140MM WERE MEASURED USING THE IVUS CATHETER THE STENT FORESHORTENED ALMOST 2CM. DID ANY 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. 3.94 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A,YES,NO. 3.95 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO. ¿ IF YES, PLEASE SPECIFY: 3.96 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER. ¿ IF OTHER, PLEASE SPECIFY: 3.97 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO. 3.98 WAS THE DEVICE USED PERCUTANEOUSLY? N/A,YES,NO. 3.99 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? 3.100 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER ¿ IF OTHER, PLEASE SPECIFY: 3.101 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? ¿ IF OTHER, PLEASE SPECIFY 3.102 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL 3.103 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO. 3.104 WHAT WAS THE TARGET LOCATION FOR THE STENT? 3.105 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 3.106 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? N/A,YES,NO. 3.107 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? 3.108 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? N/A, YES, NO. 3.109 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? N/A, YES, NO. 3.110 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.111 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? N/A,YES, NO. 3.112 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? N/A,YES, NO. 3.113 DID THE USER PUSH THE HUB DURING DEPLOYMENT? N/A, YES, NO. 3.114 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? N/A, YES, NO. 3.115 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? N/A, YES, NO. 3.116 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? N/A, YES, NO. 3.117 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? N/A, YES, NO. 3.118 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO. 3.95 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? UNKNOWN. 3.96 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) FIBROTIC, 3.97 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 3.98 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3.99 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? CFV. 3.100 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER IF OTHER, PLEASE SPECIFY:CFV. 3.102 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? IPSILATERAL 3.103 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES, 3.104 WHAT WAS THE TARGET LOCATION FOR THE STENT? CIV,EIV,CFV 3.105 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 10FR CORDIS,11CM. 3.106 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 3.107 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? JWIRE. 3.108 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 3.109 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION?, NO. 3.110 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.111 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. 3.112 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? YES. 3.113 DID THE USER PUSH THE HUB DURING DEPLOYMENT?, NO. 3.114 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? YES. 3.115 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? YES. 3.116 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? YES. 3.117 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? YES. 3.118 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES. 3.119 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. 3.121 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NO. 3.122 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? NO. 3.119 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? N/A, YES, NO. 3.120 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 3.121 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 3.122 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO. ¿ PLEASE SPECIFY IF YES. 3.95 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? UNKNOWN. 3.96 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) FIBROTIC, 3.97 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 3.98 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3.99 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE?CFV. 3.100 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER ¿ IF OTHER, PLEASE SPECIFY:CFV. 3.102 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? IPSILATERAL 3.103 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES, 3.104 WHAT WAS THE TARGET LOCATION FOR THE STENT? CIV,EIV,CFV. 3.105 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 10FR CORDIS,11CM. 3.106 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 3.107 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? JWIRE. 3.108 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 3.109 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION?, NO. 3.110 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.111 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. 3.112 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? YES. 3.113 DID THE USER PUSH THE HUB DURING DEPLOYMENT?, NO. 3.114 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? YES. 3.115 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? YES. 3.116 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? YES. 3.117 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? YES. 3.118 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT?YES. 3.119 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. 3.121 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NO 3.122 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1527040 | ZILVER VENA VENOUS SELF-EXPANDING STENT | QAN | COOK IRELAND LTD | G57449 | C1847298 | 10827002574493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |