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

Model Number	40S06
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Thrombosis (2100); Stenosis (2263)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately 908 days post implantation, the patient experienced infection of vascular access.The patient was hospitalized and treated with antibiotics.The patient was discharged one day post admittance.The current status of the patient is unknown.New information: it was reported through the results of a clinical trial, that approximately 1092 days post implantation, the patient experienced pseudo-aneurysm of vascular access.The patient was hospitalized and discharged one day post admittance.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned.The investigation is inconclusive for the reported event.Based upon the available information, the definitive root cause is unknown.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.H10: g4, h6 (patient: 2605, method, conclusions).H11: a2, b3, b5, g3, h6 (device).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.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately 16 months, 22 months, 25 months post study conduit placement, the subject experienced thrombosis of vascular access, approximately 26 months post study conduit placement, the subject experienced stenosis of vascular access.It was further reported approximately 29 months post study conduit placement the subject experienced infection of vascular access and was hospitalized and treated with antibiotics.The patient was discharged the following day.Approximately 30 months post study conduit placement, the subject experienced stenosis of vascular access.Approximately 30 months post study conduit placement, the subject experienced thrombosis of vascular access and was hospitalized.Percutaneous transluminal angioplasty was performed and follow up test demonstrated patency and the event was resolved.The subject was discharged the following day in stable condition.Approximately 35 months post study conduit placement, the patient experienced pseudoaneurysm of vascular access and was hospitalized and discharged the following day.The current patient status is unknown.

• Brand Name: IMPRA VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10113098
• Report Number: 2020394-2020-03594
• Device Sequence Number: 3636398
• Product Code: DYF
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K004012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID; CALCIUM ACETATE; CALCIUM ACETATE; ERYTHROPOIETIN; ERYTHROPOIETIN; FUROSEMIDE; FUROSEMIDE; NADROPARIN CALCIUM; NADROPARIN CALCIUM; RANITIDINE; RANITIDINE; ACETYLSALICYLIC ACID; CALCIUM ACETATE; ERYTHROPOIETIN; FUROSEMIDE; NADROPARIN CALCIUM; RANITIDINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 77