MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT

Model Number	45A64
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event 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 placement of a expanded polytetrafluoroethylene graft, weeping of the graft was noted.The physician was able to alleviate the weeping and the graft was left in place.There was no reported patient injury.
Additional Manufacturer Narrative
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.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for any type of leak in the graft as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instruction for use (ifu) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.Avoid repeated or excessive clamping at the same location on the graft.If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.Exposure to solutions (e.G., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft¿s hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage.Preclotting of this graft is unnecessary.Avoid excessive graft manipulation after exposure to blood or body fluids.Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft¿s hydrophobic properties may occur.Loss of the hydrophobic barrier may result in graft wall leakage.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 a vascular graft, weeping of the graft was noted.The physician was able to alleviate the weeping and the graft was left in place.There was no reported patient injury.

• Brand Name: IMPRA EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6616841
• Report Number: 2020394-2017-00583
• Device Sequence Number: 16330377
• Product Code: DSY
• UDI-Device Identifier: 00801741022135
• UDI-Public: (01)00801741022135(17)220127(10)VTBN0791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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 Expiration Date: 01/27/2022
• Device Model Number: 45A64
• Device Catalogue Number: 45A64
• Device Lot Number: VTBN0791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1