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

Model Number DFM8006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

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 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 Description

It was reported that the vascular graft allegedly tore.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 graft was returned in two segments; however, the entirety of the graft appears to have been returned for evaluation.One segment of the returned sample exhibited a tear in the cuff of the device.No other tear was noted in the returned segments.The beading was intact along the length of both segments returned.Therefore, the investigation was confirmed for a tear in the graft material.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.

Event Description

It was reported that the vascular graft allegedly tore.There was no reported patient injury.

• 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: 7247898
• MDR Text Key: 99236949
• Report Number: 2020394-2018-00063
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741000164
• UDI-Public: (01)00801741000164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: DFM8006SC
• Device Catalogue Number: DFM8006SC
• Device Lot Number: VTBX0577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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