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

Catalog Number DFX6006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

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 after completion of the distal anastomosis, without trauma, two alleged slices were identified in the prosthesis, near the anastomosis.Reportedly, another vascular graft was used and the procedure was completed.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 two segments had two blue lines running down the length of the graft and carbon inner lining, thus identifying it as a bard product.The first segment measured 62.6cm from the cut and/or torn end of the graft to the distal end of the graft.The beading was intact along the length of the segment.No tear, perforation, sutures, or suture holes were present along the length of the segment.The second segment measures approximately 2.0cm in length.The segment was noted to be torn and twisted.There was a suture present in the segment.Segment of the graft measured approximately 64.6cm in total length.This measurement was within specification.Therefore, the entirety of the graft was returned for evaluation.Functional/performance evaluation: the sample was returned; however, functional/performance evaluation was not required for this device.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 returned.The investigation was confirmed for torn material, as the second segment returned exhibited a tear around the suture.It was unknown if procedural issues contributed to the reported event.Based on the available information, the definitive root cause was unknown.Labeling review: the current instruction for use (ifu) states: 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.The distal anastomosis should be made after tunneling or suture disruption can occur.Do not pass the cuff portion (distal end) of the distaflo bypass graft through a tunneler sheath or the tissue tunnel, as this could lead to separation of the spiral beading and/or graft breakage.Distaflo bypass grafts do not stretch (are non-elastic) in the longitudinal direction.The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation.Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death.When suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel.Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption.Size the graft appropriately to minimize excessive tension at the suture line.Use a tapered, non-cutting needle with a nonabsorbable monofilament suture approximately the same size as the needle.Take 2 mm suture bites in the graft following the curve of the needle and gently pull the suture at a 90° angle.Proper sizing of the graft length prior to implant will minimize suture hole elongation caused by excessive tension.To avoid extreme stress on the anastomosis and the graft, include the patient¿s weight and range of limb motion when determining graft length, tunnel length and location.To determine the correct graft length, drape the patient to allow full movement of the arm, shoulder girdle or legs.Cutting the graft slightly longer than necessary has been reported by some surgeons to further reduce the risk of stressing the graft or the anastomosis.(b)(4).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 after completion of the distal anastomosis in the lower extremities, without trauma, two alleged slices were identified in the prosthesis, near the anastomosis.Reportedly, another vascular graft was used and the procedure was completed.There was no reported patient injury.

• Brand Name: DISTAFLO MINI 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: 6247698
• MDR Text Key: 64735173
• Report Number: 2020394-2016-01258
• Device Sequence Number: 1
• Product Code: DYF
• UDI-Device Identifier: 00801741023651
• UDI-Public: (01)00801741023651(17)210524(10)VTAS0740
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K983769
• 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: 12/20/2016

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: 05/24/2021
• Device Catalogue Number: DFX6006SC
• Device Lot Number: VTAS0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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