FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Report
- Report Number
- 2020394-2024-01174
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- July 11, 2024
- Report Date
- August 7, 2024
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- PFV
- PMA / PMN Number
- P130029
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 03/2027) H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: MANUFACTURING REVIEW: BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. HOWEVER, THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. INVESTIGATION SUMMARY: THE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. THE DELIVERY MECHANISM WAS FULLY ACTIVATED; THE STENT GRAFT WAS COMPLETELY DEPLOYED AND MISSING, AS IT HAD BEEN PLACED IN THE PATIENT. THE DISTAL PART OF THE OUTER CATHETER INCLUDING THE RADIOPAQUE MARKER BAND WAS MISSING WHICH LEADS TO CONFIRMED RESULT FOR SHEATH BREAK AND DETACHMENT. IT WAS REPORTED THAT A 7F INTRODUCER/0.035" GUIDEWIRE WERE USED FOR ACCESS, THE TRACKING VESSEL WAS NEITHER TORTUOUS NOR CALCIFIED, THE LESION WAS PRE-DILATED, AND THE DEVICE WAS FLUSHED BEFORE USE. BASED ON THE PROVIDED INFORMATION AND THE EVALUATION OF THE RETURNED SAMPLE, THE INVESTIGATION IS CLOSED WITH CONFIRMED RESULTS FOR BREAK AND DETACHMENT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING, IT WAS FOUND THAT THE INSTRUCTIONS FOR USE SUFFICIENTLY ADDRESS THE POTENTIAL RISKS. THE INSTRUCTIONS FOR USE STATE: 'IF UNUSUAL RESISTANCE OR HIGH DEPLOYMENT FORCE IS ENCOUNTERED DURING STENT GRAFT DEPLOYMENT, ABORT THE PROCEDURE, REMOVE THE DELIVERY SYSTEM AND USE AN ALTERNATIVE DEVICE'. REGARDING PREPARATION OF THE DEVICE THE INSTRUCTIONS FOR USE STATE THAT "PRIOR TO LOADING THE VASCULAR SYSTEM OVER A GUIDE WIRE, BOTH PORTS MUST BE FLUSHED WITH STERILE SALINE. FLUSHING THESE LUMENS WILL ALSO FACILITATE STENT GRAFT DEPLOYMENT". REGARDING THE ANATOMY OF THE PLACEMENT SITE THE INSTRUCTIONS FOR USE STATES: "PRIOR TO STENT GRAFT DEPLOYMENT, ENSURE THAT THE PROXIMAL STENT GRAFT END IS POSITIONED IN A STRAIGHT SECTION OF THE LUMEN TO REDUCE THE RISK OF INCREASED DEPLOYMENT FORCES AND POSSIBLE FAILURE TO DEPLOY". REGARDING ACCESSORIES THE INSTRUCTIONS FOR USE STATES: "PREPARE A STIFF 0.035" GUIDEWIRE PER ITS INSTRUCTIONS FOR USE AND ADVANCE THE GUIDEWIRE UNDER FLUOROSCOPY TO THE TARGET LOCATION. THE USE OF AN APPROPRIATELY SIZED INTRODUCER SHEATH IS RECOMMENDED". THE PACKAGING PICTOGRAMS INDICATE AN INTRODUCER SIZE OF 10F AND A 0.035" GUIDEWIRE. WITH REGARDS TO STENT PLACEMENT, THE INSTRUCTIONS FOR USE STATES "POST DILATE THE STENT GRAFT WITH AN ANGIOPLASTY BALLOON SIZED APPROPRIATELY AS TO ENSURE COMPLETE WALL APPOSITION TO THE REFERENCE VESSEL". THE INSTRUCTIONS FOR USE ALSO MENTIONS DETACHMENT OF DEVICE PARTS AS A POTENTIAL COMPLICATION. H10: D4 (EXPIRATION DATE: 03/2027), G3. H11: H6 (RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT CEPHALIC ARCH VIA LEFT UPPER ARM FISTULA, THE TIP/SPRING PORTION OF THE END OF THE STENT WAS ALLEGEDLY AND THE STENT WOULD NOT FLARE OPEN. IT WAS FURTHER REPORTED THAT WHEN TRYING TO BALLOON UP THE STENT, THE TIP/SPRING PORTION OF THE END OF THE STENT WAS ALLEGEDLY DISLODGED. REPORTEDLY, THE DISLODGED PIECE OF THE STENT ENDED UP GOING TO THE LUNG. THE CURRENT STATUS OF PATIENT IS UNKNOWN.
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT CEPHALIC ARCH VIA LEFT UPPER ARM FISTULA, THE TIP/SPRING PORTION OF THE END OF THE STENT WAS ALLEGEDLY AND THE STENT WOULD NOT FLARE OPEN. IT WAS FURTHER REPORTED THAT WHEN TRYING TO BALLOON UP THE STENT, THE TIP/SPRING PORTION OF THE END OF THE STENT WAS ALLEGEDLY DISLODGED. REPORTEDLY, THE DISLODGED PIECE OF THE STENT ENDED UP GOING TO THE LUNG. THE CURRENT STATUS OF PATIENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592931 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | ENDOVASCULAR STENT GRAFT | PFV | BARD PERIPHERAL VASCULAR, INC. | ANJQ1814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |