BIOMIMICS 3D VASCULAR STENT SYSTEM
Report
- Report Number
- 3011632150-2023-00020
- Event Type
- Malfunction
- Date Received
- February 15, 2023
- Date of Event
- January 17, 2023
- Report Date
- April 6, 2023
- Manufacturer
- VERYAN MEDICAL LTD.
- Product Code
- NIP
- UDI-DI
- 05391526850510
- PMA / PMN Number
- P180003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION IS IN PROGRESS AND THE DEVICE HAS BEEN RETURNED FOR EVALUATION. ANY ADDITIONAL INFORMATION THAT BECOMES AVAILABLE WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
A DETAILED REVIEW OF ALL THE LOT HISTORY RECORDS PERTAINING TO THE RELEVANT STENT AND DELIVERY SYSTEM LOT SHOWED NO ISSUES THAT WERE DEEMED RELATED TO THE COMPLAINT INVESTIGATION. THE DELIVERY SYSTEM WAS RECEIVED WITH FRACTURED STENT CROWNS PROTRUDING FROM THE DISTAL OUTER BRAID. THERE WAS SLIGHT DAMAGE TO THE RADIOPAQUE MARKER AND DISTAL OUTER BRAID. THE FRACTURED CROWNS AND DISTAL OUTER BRAID WERE EXAMINED UNDER THE MICROSCOPE, AND THE DAMAGE NOTED TO THE RADIOPAQUE MARKER AND DISTAL OUTER BRAID COINCIDED WITH THE PROTRUDING FRACTURED STENT CROWNS AND IS BELIEVED TO HAVE BEEN CAUSED BY THE PARTIAL DEPLOYMENT. THERE WAS NO DAMAGE TO THE DISTAL TIP. A SEVERE CAST WAS OBSERVED THROUGH THE DISTAL PORTION OF THE DEVICE AS WELL AS SIGNIFICANT CURL UP. THIS WAS BELIEVED TO BE DUE TO THE MANNER THE DEVICE WAS PACKAGED FOR RETURN. THE LENGTH OF THE OUTER BRAID WAS MEASURED AND WAS OUTSIDE THE SPECIFICATION LENGTH FOR THE EFFECTIVE LENGTH OF THE CATHETER, CONFIRMING THAT THE DEVICE WAS SUBJECTED TO SIGNIFICANT TENSILE FORCE DURING USE. THE BONDS OF THE DELIVERY SYSTEM WERE CHECKED AND ALL WERE INTACT EXCEPT THE BIFURCATION HUB TO OUTER BRAID BOND WHICH HAD SEPARATED. THE PRESENCE OF SANDING MARKS ON THE PROXIMAL END OF THE OUTER BRAID AND RESIDUAL GLUE PRESENT IN THE BIFURCATION HUB PORT AS WELL AS ON THE INSIDE SURFACE THAT RETAINS THE OUTER BRAID INDICATED THAT THE MANUFACTURING STEPS WERE PERFORMED AS INTENDED. AN ATTEMPT WAS MADE TO DEPLOY THE STENT, WHERE THE PROXIMAL LUER WAS PINNED AND STABILISED AND THE OUTER BRAID WAS RETRACTED. THE DEPLOYMENT RESULTED IN RELEASE OF 15 ADDITIONAL STENT CROWNS WITH LOW FORCE REQUIRED. THE FULL STENT RELEASE WAS NOT POSSIBLE AS ALL THE REMINING STOKE LENGTH HAD BEEN USED. THE COMPLAINT REPORTED NOTED THAT ROUGHLY 60 MM OF STENT REMAINED INSIDE THE PATIENT, AND DURING THE RETURNED DEVICE INVESTIGATION A FURTHER 55 MM OF THE STENT WERE RELEASED FROM THE BRAID. THEREFORE, ROUGHLY 35 MM OF THE STENT REMAINED WITHIN THE OUTER BRAID. A REVIEW OF THE IN-PROCESS FUNCTIONAL TEST DATA SHOWED THAT THE LOT PASSED THE MONITORING AND WAS MANUFACTURED AS INTENDED. THE BIFURCATION HUB AND OUTER BRAID BOND SEPARATION ALONG WITH THE OUTER BRAID ELONGATION SUGGESTS THAT THERE WAS A HIGH DEPLOYMENT FORCE. SEVERE CALCIFICATION AND TORTUOUS VESSEL ANATOMY CAN CREATE FRICTION BETWEEN THE DELIVERY SYSTEM COMPONENTS AND BETWEEN THE VESSEL AND DELIVERY SYSTEM LEADING TO HIGH DEPLOYMENT FORCE. DIFFICULTY TO DEPLOY EVENTS DUE TO INCREASED FORCE DURING DEPLOYMENT CAN LEAD TO A FRACTURED STENT AND PROLONGED PROCEDURES IF THE PHYSICIAN MUST ABORT THE DEPLOYMENT FOLLOWING A PARTIAL DEPLOYMENT. THE MOST LIKELY CAUSE OF DIFFICULTY WITH THE DEPLOYMENT IN THIS CASE WAS THE LEVEL OF DISEASE AND CHALLENGING VESSEL ANATOMY. THE COMPLAINT WAS CATEGORISED AS A "PARTIAL DEPLOYMENT" WITH CAUSE CATEGORIES "ANATOMY" AND "DISEASE PROGRESSION".
ON (B)(6) 2023, A VERYAN REPRESENTATIVE WAS MADE AWARE THAT DURING IMPLANTATION OF A 6 X 150MM BIOMIMICS 3D (BM3D) STENT, THE STENT COULD NOT BE FULLY DEPLOYED. THE VESSEL ANATOMY WAS DESCRIBED AS EXTREMELY TORTUOUS AND SEVERELY CALCIFIED. THE TARGET SITE WAS PREPARED USING CARDIOVASCULAR SYSTEMS INC (CSI) ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE BM3D DEVICE WAS INTRODUCED AND ADVANCED TO THE TARGET SITE. THE PHYSICIAN STARTED DEPLOYING THE DEVICE BUT AFTER 60MM OF STENT DEPLOYMENT, THE PHYSICIAN WAS UNABLE TO DEPLOY THE REMAINDER OF THE STENT. THE STENT SUBSEQUENTLY FRACTURED AND THE DEVICE WAS REMOVED, LEAVING A PORTION OF THE STENT IN THE PATIENT'S VESSEL. THIS WAS RELINED WITH A COMPETITOR STENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
ON (B)(6) 2023, THE PHYSICIAN ATTEMPTED TO DEPLOY A BIOMIMICS 3D (BM3D) 6.0 X 150MM STENT IN THE POPLITEAL ARTERY. THE VESSEL WAS SEVERELY CALCIFIED AND TORTUOUS WITH MULTIPLE OCCLUSIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED WITH A BIOTRONIK® FORTRESS 6 FRENCH (6F) ACCESS SHEATH. THE TARGET SITE WAS PREPARED USING LASER ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE DEVICE WAS FLUSHED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) PRIOR TO INSERTION. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DELIVERY SYSTEM, AND NO ISSUES WHEN CROSSING THE AORTIC BIFURCATION. ON REACHING THE TARGET SITE, THE PHYSICIAN DEPLOYED APPROXIMATELY 60MM OF THE STENT, AND THEN EXPERIENCED SIGNIFICANT RESISTANCE WHICH PREVENTED FURTHER DEPLOYMENT OF THE DEVICE. IN RESPONSE TO THE RESISTANCE, THE PHYSICIAN BEGAN MANIPULATING THE DELIVERY SYSTEM TO TRY AND DEPLOY THE REMAINDER OF THE STENT. A SECOND PHYSICIAN WAS CALLED TO TRY AND DEPLOY THE STENT. DURING THIS MANIPULATION OF THE DEVICE THE STENT FRACTURED, THE BIFURCATED HUB REACHED THE PROXIMAL LUER AND THE BIFURCATED HUB TO OUTER SHEATH BOND SEPARATED. THERE WAS NO RESISTANCE FELT ON REMOVAL OF THE DELIVERY SYSTEM. A COMPETITOR STENT WAS USED TO RELINE THE BROKEN PORTION OF BM3D STENT. THE PHYSICIAN REPORTED DIFFICULTY WITH THIS DEPLOYMENT ALSO. NO ADDITIONAL VESSEL PREPARATION WAS CONDUCTED BEFORE PLACEMENT OF THE COMPETITOR STENT. THE PARTIAL DEPLOYMENT AND SUBSEQUENT FRACTURE OF THE BM3D STENT RESULTED IN A PROLONGED PROCEDURE AS THE FRACTURED PORTION HAD TO BE RELINED WITH ANOTHER STENT. THERE WAS NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318308 | BIOMIMICS 3D VASCULAR STENT SYSTEM | BIOMIMICS 3D VASCULAR STENT SYSTEM | NIP | VERYAN MEDICAL LTD. | 144700-12 | 0000141674 | 05391526850510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |