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

Model Number	VLT4046C
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Swelling (2091); Thrombus (2101)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) 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.(expiration date: 06/2023).
Event or Problem Description
It was reported one day post vascular graft placement, there was no murmur or tremor.Ultrasound demonstrated thrombi within the graft and the graft was removed and revealed a collapsed lumen.A new graft was placed and blood flow was restored.The current patient status was not provided.
Event or Problem Description
It was reported one day post vascular graft placement, there was no murmur or tremor.Reportedly an ultrasound demonstrated thrombi within the graft and the graft was removed and revealed a collapsed lumen.A new graft was placed and blood flow was restored.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and determined that a manufacturing review was not required.Investigation summary:the investigation is inconclusive for the reported obstruction of flow within the lumen of the graft as the device was not returned for evaluation.The definitive root cause for the reported obstruction of flow within the lumen of the graft could not be determined based up on the available information.Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: VENAFLO VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10453738
• Report Number: 2020394-2020-05504
• Device Sequence Number: 4284118
• Product Code: DSY
• UDI-Device Identifier: 00801741020582
• UDI-Public: (01)00801741020582
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: VLT4046C
• Device Catalogue Number: VLT4046C
• Device Lot Number: VTCT0250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR