ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00440
- Event Type
- Malfunction
- Date Received
- June 6, 2023
- Date of Event
- July 23, 2022
- Report Date
- July 31, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA 510K # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P200023; INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA 510K # P200023. THIS FILE WAS CREATED FROM LITERATURE " SANTILLÁN-AGUAYO 2022" TO CAPTURE OFF LABEL USE. 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. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. REVIEW HISTORICAL DATA: N/A. INSTRUCTIONS FOR USE AND/LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. AS PER MEDICAL ADVISOR "ZILVER VENA WAS DEPLOYED THROUGH A DILATED CELL OF A PRE-EXISTING STENT INTO SUPERIOR VENA CAVA VIA A RIGHT JUGULAR APPROACH. ALL OF WHICH WAS OFF-LABEL USE." IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: 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 THROUGH A DILATED CELL OF A PRE-EXISTING STENT INTO SUPERIOR VENA CAVA VIA A RIGHT JUGULAR APPROACH, THIS IS CONSIDERED OFF LABEL USE. 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 OF INVESTIGATION: ACCORDING TO THE CUSTOMER, PLACEMENT OF COOK ZILVER VENA IN THE SUPERIOR VENA CAVA CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, PATIENT OUTCOME WAS THROMBOSIS, ENDOTHELIAL INJURY, SUBCAPSULAR RENAL HEMATOMA. IT MAY BE NOTED THAT AS PER MEDICAL ADVISOR INPUT: "HOWEVER, THESE AES WERE NOT A RESULT OF THE OFF-LABEL USE ¿ THROMBOSIS ¿ DUE TO EXCESSIVE SURGICAL TIME ~6 HOURS ENDOTHELIAL INJURY ¿ SECONDARY TO A PORT CATHETER RENAL HEMATOMA ¿ WAS A PRE-EXISTING CONDITION I.E., A HISTORY OF SUBCAPSULAR HEMATOMA ASSOCIATED WITH INTRAOPERATIVE ANTICOAGULATION". INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED 07-JUN-2023 SANTILLÁN-AGUAYO , 2022, IATROGENIC SUPERIOR VENA CAVA SYNDROME: DESCRIPTION OF AN ENDOVASCULAR APPROACH THROUGH A CASE AND LITERATURE REVIEW STEP I - RIGHT JUGULAR ACCESS: PATENT RIGHT BRACHIOCEPHALIC TRUNK THROMBOSED LEFT BRACHIOCEPHALIC STENT OCCLUDING SVC. STEP II - 0.035 HYDROPHILIC GUIDEWIRE CROSSING STRUTS OF THE STENT. STEP III - PRE-DILATION THROUGH THE CELLS FROM 8 MM TO 16 MM BALLONS. STEP VI - ZILVER VENA STENT PLACEMENT (60×14×60 MM). RESIDUAL STENOSIS JUST AT THE SITE OF CROSSING CELLS (HOURGLASS IMAGE). STEP V - POST-DILATION FROM 8 MM TO 16 MM BALLONS. STEP VI - FINAL RESULT. RIGHT JUGULAR APPROACH (STEP I) CROSSING THE STRUTS OF THE LEFT BRACHIOCEPHALIC STENT WITH A HYDROPHILIC GUIDEWIRE (STEP II) THROUGH THE OCCLUDED SUPERIOR VENA CAVA TO THE INFERIOR VENA CAVA (TABLE 2). PRE-DILATION IS REQUIRED (STEP III) DUE TO THE CROSSING OF THE STRUTS OF THE STENT, ALLOWING THE STRUCTURAL MODIFICATION OF THE STRUTS (CRUSHING) AND THE PLACEMENT OF A ZILVER VENA STENT 60 × 14 × 60 MM (STEP IV), ALWAYS OBSERVING A RESIDUAL CONSTRICTION JUST AT THE SITE OF THE CROSSING CELLS, WHICH WE CALL IT AN HOURGLASS IMAGE. FINALLY POST-DILATION WAS PERFORMED (STEP V) WITH CONTROL PHLEBOGRAPHY (STEP VI) (FIG. 1). IN THIS CASE, DURING POST-DILATION STEP (V), THE GUIDEWIRE WAS PULLED BY MISTAKE AND LOST WITHOUT BEING ABLE TO CANNULATE THE SAME STRUT AGAIN, SO THE PROCEDURE WAS REPEATED ONCE MORE, THROUGH ANOTHER CELL, WITH THE SAME PRE-DILATATION PROGRESSION, AND THE SAME STENT. FINAL PHLEBOGRAPHY SHOWED PARTIAL IN-STENT THROMBOSIS BUT ABUNDANT COLLATERAL CIRCULATION. AT THE END OF THE PROCEDURE, THE PATIENT EXPERIENCED THE DISAPPEARANCE OF FACIAL CONGESTION AND RELIEF OF THE DYSPNEA AS A SIGN OF A MARKED INCREASE IN VENOUS RETURN, IMMEDIATELY AFTER STENT RELEASE, DESPITE IN-STENT THROMBOSIS. OFF LABEL USE: PLACEMENT OF COOK ZILVER VENA IN THE SUPERIOR VENA CAVA.
SANTILLÁN-AGUAYO , 2022, IATROGENIC SUPERIOR VENA CAVA SYNDROME: DESCRIPTION OF AN ENDOVASCULAR APPROACH THROUGH A CASE AND LITERATURE REVIEW STEP I - RIGHT JUGULAR ACCESS: PATENT RIGHT BRACHIOCEPHALIC TRUNK THROMBOSED LEFT BRACHIOCEPHALIC STENT OCCLUDING SVC; STEP II - 0.035 HYDROPHILIC GUIDEWIRE CROSSING STRUTS OF THE STENT; STEP III - PRE-DILATION THROUGH THE CELLS FROM 8 MM TO 16 MM BALLONS; STEP VI - ZILVER VENA STENT PLACEMENT (60×14×60 MM). RESIDUAL STENOSIS JUST AT THE SITE OF CROSSING CELLS (HOURGLASS IMAGE); STEP V - POST-DILATION FROM 8 MM TO 16 MM BALLONS; STEP VI - FINAL RESULT; RIGHT JUGULAR APPROACH (STEP I) CROSSING THE STRUTS OF THE LEFT BRACHIOCEPHALIC STENT WITH A HYDROPHILIC GUIDEWIRE (STEP II) THROUGH THE OCCLUDED SUPERIOR VENA CAVA TO THE INFERIOR VENA CAVA (TABLE 2). PRE-DILATION IS REQUIRED (STEP III) DUE TO THE CROSSING OF THE STRUTS OF THE STENT, ALLOWING THE STRUCTURAL MODIFICATION OF THE STRUTS (CRUSHING) AND THE PLACEMENT OF A ZILVER VENA STENT 60 × 14 × 60 MM (STEP IV), ALWAYS OBSERVING A RESIDUAL CONSTRICTION JUST AT THE SITE OF THE CROSSING CELLS, WHICH WE CALL IT AN HOURGLASS IMAGE. FINALLY POST-DILATION WAS PERFORMED (STEP V) WITH CONTROL PHLEBOGRAPHY (STEP VI) (FIG. 1). IN THIS CASE, DURING POST-DILATION STEP (V), THE GUIDEWIRE WAS PULLED BY MISTAKE AND LOST WITHOUT BEING ABLE TO CANNULATE THE SAME STRUT AGAIN, SO THE PROCEDURE WAS REPEATED ONCE MORE, THROUGH ANOTHER CELL, WITH THE SAME PRE-DILATATION PROGRESSION, AND THE SAME STENT. FINAL PHLEBOGRAPHY SHOWED PARTIAL IN-STENT THROMBOSIS BUT ABUNDANT COLLATERAL CIRCULATION. AT THE END OF THE PROCEDURE, THE PATIENT EXPERIENCED THE DISAPPEARANCE OF FACIAL CONGESTION AND RELIEF OF THE DYSPNOEA AS A SIGN OF A MARKED INCREASE IN VENOUS RETURN, IMMEDIATELY AFTER STENT RELEASE, DESPITE IN-STENT THROMBOSIS. PATIENT OUTCOME: THROMBOSIS, ENDOTHELIAL INJURY, SUBCAPSULAR RENAL HEMATOMA.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 31-JUL-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674659 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |