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

Model Number VTAQ0392

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

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 Description

It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft.There was no reported patient injury.

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.This is the only complaint that has been reported for this corporate lot number to date.Visual inspection: the returned graft segment measured approximately 2.8 cm in length.Both ends of the returned segment had been cut.There were no suture holes identified along the length of the returned segment.The beading was pealed along segment of graft.Partial circumferential tears were noted along the beading track on the graft.The total length of the graft was measured to be approximately 2.8cm.This measurement was not within specification indicating the entirety of the graft was not returned.Functional/performance evaluation: the sample was returned; however, functional/performance evaluation is not required.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: two digital photos were provided and reviewed by the fa engineer.The first photo showed a partial graft segment in a clear plastic bag on a black background.The beading appeared to be removed in the photo.What appeared to be a small circumferential tear along the beading track of the graft.The second photo showed the graft being implanted into the patient.One end of the graft appeared to be sutured into place.A circumferential tear was identified on the graft.The beading was removed on the graft up to the tear.Based on the provided images the investigation was confirmed for torn material.Conclusion: the device was returned.Photos were provided.The investigation was confirmed for torn material along the beading track of the graft.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 performed to investigate the bead tear issue across eptfe vascular graft products.Labeling review: the current ifu states: precautions when removing the external spiral support (beading) of the graft, 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 an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft.There was no reported patient injury.

• Brand Name: DISTAFLO BYPASS 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: 6244267
• MDR Text Key: 64617878
• Report Number: 2020394-2016-01253
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023644
• UDI-Public: (01)00801741023644(17)210313(10)VTAQ0392
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K983861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: VTAQ0392
• Device Catalogue Number: DFM7006SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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