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

Catalog Number F7008TWS

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device is not available for return.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 Description

It was reported that during preparation, upon removal of the beading from the vascular graft, the graft allegedly tore.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was not returned.Images and medical records were not provided.The investigation was inconclusive for the alleged graft tears.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Further investigation is being conducted to investigate the bead tear issue in eptfe vascular graft products.Labeling review: the current ifu (instructions for use) states: warnings: do not remove the external spiral support (beading) from any centerflex¿ graft or endflex¿ graft.Attempts to remove the beading may damage the graft wall.If damage occurs, discard the graft.Precautions: when removing the external spiral support (beading) of impra flex¿ grafts, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and/or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.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 Description

It was reported that during preparation, upon removal of the beading from the vascular graft, the graft allegedly tore.There was no reported patient contact.

• Brand Name: IMPRA VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6248033
• MDR Text Key: 64727954
• Report Number: 2020394-2016-01263
• Device Sequence Number: 1
• Product Code: DYF
• UDI-Device Identifier: 00801741023279
• UDI-Public: (01)00801741023279(17)210110(10)VTAN0270
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K983064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: F7008TWS
• Device Lot Number: VTAN0270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR