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

Model Number DFM8006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

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 was not returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during placement of an eptfe vascular graft, upon manipulation of the graft while suturing, the graft allegedly tore.The torn material of the vascular graft was removed and the procedure was completed.There was no reported patient injury.

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.Investigation summary:the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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: 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 patients 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.

Event Description

It was reported that during placement of an eptfe vascular graft, upon manipulation of the graft while suturing, the graft allegedly tore.It was further reported that the torn material of the vascular graft was removed and the procedure was completed.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: 7003615
• MDR Text Key: 91507664
• Report Number: 2020394-2017-01509
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741000164
• UDI-Public: (01)00801741000164
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K983861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: DFM8006SC
• Device Catalogue Number: DFM8006SC
• Device Lot Number: VTBR0144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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