FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Report
- Report Number
- 9681442-2016-00266
- Event Type
- Malfunction
- Date Received
- October 12, 2016
- Date of Event
- September 13, 2016
- Report Date
- September 18, 2016
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- PFV
- UDI-DI
- 04049519008608
- PMA / PMN Number
- P130029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.
THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE CONDITION OF THE RETURNED SAMPLE, THE REPORTED EVENT WAS CONFIRMED. THE STENT GRAFT WAS FOUND TO BE PARTIALLY DEPLOYED UPON SAMPLE RECEIPT; THE OUTER SHEATH OF THE DELIVERY SYSTEM WAS FOUND TO BE FRACTURED. THE CONDITION OF THE SAMPLE, IN PARTICULAR ELONGATION AND FRACTURE OF THE OUTER SHEATH INDICATES THAT HIGH FRICTION FORCES OCCURRED DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT. BASED ON SAMPLE EVALUATION NO INDICATION WAS FOUND THAT A MANUFACTURING RELATED ISSUE MAY HAVE CAUSED THIS EVENT. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE REPORTED TYPE OF EVENT MAY BE ASSOCIATED WITH A DIFFICULT PATIENT ANATOMY OR A CHALLENGING PLACEMENT SITE. USAGE OF INADEQUATE ACCESSORIES OR INSUFFICIENT FLUSHING OF THE DEVICE PRIOR TO USE MAY BE CONTRIBUTING FACTORS. ON THE BASIS OF THE AVAILABLE INFORMATION AND THE EVALUATION OF THE RETURNED SAMPLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE IFU STATES: "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 IFU STATES: "PRIOR TO LOADING THE ENDOVASCULAR 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 IFU STATES: ¿THE SAFETY AND EFFECTIVENESS OF THE DEVICE WHEN PLACED ACROSS A TIGHT BEND (...) HAS NOT BEEN EVALUATED. PRIOR TO STENT GRAFT DEPLOYMENT, ENSURE THAT THE PROXIMAL (INFLOW) STENT GRAFT END IS POSITIONED IN A STRAIGHT SECTION OF THE LUMEN TO REDUCE THE RISK OF HIGHER DEPLOYMENT FORCES AND POSSIBLE ENDOVASCULAR SYSTEM FAILURE.¿ REGARDING USE OF ACCESSORIES THE IFU STATES: "MATERIAL REQUIRED FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PROCEDURE (...) INTRODUCER SHEATH WITH APPROPRIATE INNER DIAMETER."
IT WAS REPORTED THAT DURING A SHEATHLESS STENT GRAFT PLACEMENT PROCEDURE FOR TREATMENT OF A PRE-DILATED LEFT SUBCLAVIAN VEIN STENOSIS (THE PATIENT HAD A LEFT UPPER ARM GRAFT), THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, RESISTANCE WAS FELT WHEN TRYING TO RELEASE THE STENT GRAFT. THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A SHEATHLESS STENT GRAFT PLACEMENT PROCEDURE FOR TREATMENT OF A PRE-DILATED LEFT SUBCLAVIAN VEIN STENOSIS (THE PATIENT HAD A LEFT UPPER ARM GRAFT), THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, RESISTANCE WAS FELT WHEN TRYING TO RELEASE THE STENT GRAFT. THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673009 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | ENDOVASCULAR STENT GRAFT | PFV | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANAR4165 | 04049519008608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |