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

Model Number F8006TWSC

Device Problem Torn Material (3024)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.Medical device images were provided.The image review and investigation of the reported event is currently underway.

Event Description

It was reported that five weeks post implant of a vascular graft for an axillo-femoral bypass procedure, the patient allegedly had pain.A ct angiogram revealed that there was a five centimeter separation between the torn graft.Another vascular graft was placed to connect the two ends of the graft.

Manufacturer Narrative

Manufacturing review: the lot number has been 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 for this lot number and issue to date.Investigation summary: the device was not returned for evaluation.However, one digital photo was provided for review.In the photo two ends of a graft could be identified; the two segments were connected by eptfe beading that surround the graft.Therefore, the investigation can be confirmed for torn material.The root cause could not be determined based upon available information.It is unknown whether procedural factors and/or patient factors contributed to the event.Labeling review: the current instruction for use (ifu) states: eptfe 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.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.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.

Event Description

It was reported that five weeks post implant of a vascular graft for an axillo-femoral bypass procedure, the patient allegedly had pain.A ct angiogram revealed that there was a five centimeter separation between the torn graft.Another vascular graft was placed to connect the two ends of the graft.

• Brand Name: CARBOFLO EPTFE 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: 6909737
• MDR Text Key: 87983956
• Report Number: 2020394-2017-01264
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021626
• UDI-Public: (01)00801741021626
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K004011
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2017
• Device Model Number: F8006TWSC
• Device Catalogue Number: F8006TWSC
• Device Lot Number: VTAU0537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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 Outcome(s): Required Intervention