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

Model Number	FAS07050
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 placement of the vascular stent graft in the loop graft, the stent graft was not allegedly deployed in intended placement site.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed.There was no reported patient injury.
Additional Manufacturer Narrative
The received sample and new reported information indicates that the alleged device deficiency was incorrectly reported referencing another device lot number and catalog number.The device lot and catalog number were confirmed as (catalog #fas07050, lot #anbt3686).The reported failure mode of malposition of device was updated to failure to deploy.The event describes a failure to deploy the stent graft in an av loop vascular graft.An assessment of the mdr decision tree and the reported event details and a review of the mdr reportability guidelines have determined that a failure to deploy the stent graft is not an issue likely to cause or contribute to a serious patient injury; therefore, the event is no longer mdr reportable as a malfunction.(b)(4).
Event or Problem Description
It was reported that during placement of the vascular stent graft in the loop graft, the stent graft allegedly did not deploy.Reportedly, the device was removed without incident, and a second endovascular stent graft was deployed.There was no reported patient injury.

• 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: 7779255
• Report Number: 2020394-2018-01441
• Device Sequence Number: 1318932
• Product Code: PFV
• UDI-Device Identifier: 04049519008950
• UDI-Public: (01)04049519008950
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: FAS07050
• Device Catalogue Number: FAS07050
• Device Lot Number: ANBT3686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60