MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT

Model Number	FAF07070
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an arteriovenous fistula shunt junction procedure, after successfully placing the stent graft and retracting the endovascular stent graft delivery system, the health care provider identified the inner catheter was allegedly broken and became allegedly caught with the guidewire.It was further reported that the delivery system and guidewire were removed as one unit.Reportedly, once the delivery system and the guidewire were outside of the patient, the items were able to be separated without difficulty.There was no reported patient injury.
Event or Problem Description
It was reported that during an arteriovenus fistula shunt junction procedure, after successfully placing the stent graft and retracting the endovascular stent graft delivery system, the health care provider identified the inner catheter was allegedly broken and became allegedly caught with the guidewire.It was further reported that the delivery system and guidewire were removed as one unit.Reportedly, once the delivery system and the guidewire were outside of the patient, the items were able to be separated without difficulty.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.One partial flair guidewire lumen was returned for evaluation.Visual evaluation identified a detachment of the inner lumen and atraumatic tip.Functional testing was not viable.The investigation is confirmed for detachment, however, removal difficulty and guidewire incompatibility are inconclusive due to sample condition.The reported break is unconfirmed as the inner lumen and distal tip were actually detached from the system.The inner lumen likely detached due to the tension seen during removal issues.However, the root cause for removal issue could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).
Event or Problem Description
It was reported that during an arteriovenous fistula shunt junction procedure, after successfully placing the stent graft and retracting the endovascular stent graft delivery system, the health care provider identified the inner catheter was allegedly broken and became allegedly caught with the guidewire.It was further reported that the delivery system and guidewire were removed as one unit.Reportedly, once the delivery system and the guidewire were outside of the patient it was identified the tip of the catheter had detached and was stuck to the guidewire.No additional device was needed since the stent graft was placed and the procedure was completed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
This supplemental mdr is being submitted only to reflect that the event description was further updated for clarification.Please note that the change in event description does not impact the investigation.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one partial flair guidewire lumen was returned for evaluation.Visual evaluation identified a detachment of the inner lumen and atraumatic tip.Functional testing was not viable.The investigation is confirmed for detachment, however, removal difficulty and guidewire incompatibility are inconclusive due to sample condition.The reported break is unconfirmed as the inner lumen and distal tip were actually detached from the system.The inner lumen likely detached due to the tension seen during removal issues.However, the root cause for removal issue could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(fda device code 1069- break).

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7773906
• Report Number: 2020394-2018-01422
• Device Sequence Number: 1156032
• Product Code: PFV
• UDI-Device Identifier: 04049519008806
• UDI-Public: (01)04049519008806
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FAF07070
• Device Catalogue Number: FAF07070
• Device Lot Number: ANBX0509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 01/17/2019
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/12/2018; 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 66