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

Catalog Number DF8008SC

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 05/15/2014

Event Type  Injury  

Event Description

It was reported that after implantation of a surgical bypass graft, a leak at the bypass graft suture line was identified during the immediate post-operative recovery period.A second surgery was performed to remove and replace the bypass graft.The current pt status is unk.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history record is currently being performed.The device has not been returned to the mfr for evaluation.The investigation is currently underway.

Manufacturer Narrative

Per the reported event details, the distaflo graft was sutured to a 20-year-old gore-tex graft.It is unclear which segment of the graft, new or old, was responsible for the noted leak at the suture line; therefore, the definitive root cause could not be determined.It is also unk whether other procedural issues (i.E., suture type) contributed to the event.The current ifu (instructions for use) states: 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.

Event Description

Additional information from medical records indicate that bleeding at the incision site on the left side of the abdomen resulted in the patient losing approximately one liter of blood.The incision site was reopened and it was determined that the bleeding was caused by the suture pulling away from the bypass graft, which was then replaced with a standard 8mm ringed graft.The patient remained stable throughout the surgical procedure and during the post-operative recovery period.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The facility was able to provide new patient information, which was updated in the appropriate sections.

• Brand Name: DISTAFLO EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 3964195
• MDR Text Key: 21527633
• Report Number: 2020394-2014-00313
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DF8008SC
• Device Lot Number: VTWL0072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 81 YR
• Patient Weight: 91