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

Model Number	DFX7006SC
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombosis (2100); No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that approximately one month post bypass graft implantation in the sfa to the popliteal artery, the vascular graft was allegedly thrombosed with no blood flow to the foot.The patient underwent surgery to implant a second bypass graft.
Additional 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.Investigation summary: the device was not returned for evaluation.Therefore, the investigation is inconclusive for obstruction within device 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: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date 03/2022).
Event or Problem Description
It was reported that approximately one month post bypass graft implantation in the sfa to the popliteal artery, the vascular graft was allegedly thrombosed with no blood flow to the foot.The patient underwent surgery to implant a second bypass graft.

• Brand Name: DISTAFLO MINI-CUFF BYPASS GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8124287
• Report Number: 2020394-2018-02144
• Device Sequence Number: 16567416
• Product Code: DSY
• UDI-Device Identifier: 00801741023668
• UDI-Public: (01)00801741023668
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K983769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFX7006SC
• Device Catalogue Number: DFX7006SC
• Device Lot Number: VTBQ0012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention