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

Model Number	40S06
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombosis (2100); Stenosis (2263); Injury (2348)
Date of Event	12/10/2019
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 two years and ten months post placement of a left upper arm vascular graft, the patient experienced thrombosis and stenosis of vascular access and was admitted to the hospital.The event was considered resolved and the subject was discharged from the hospital the following day.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately two years and ten months post placement of a left upper arm vascular graft, the patient experienced thrombosis and stenosis of vascular access and was admitted to the hospital.The event was considered resolved and the subject was discharged from the hospital the following day.New information: approximately 1052 days post index procedure, the subject experienced bleeding of vascular access and was hospitalized.The same day, surgery was performed to treat the bleeding.If was further reported that 1055 days post index procedure, the subject underwent a thrombectomy for thrombosis of the vascular access.Post-procedure phlebography revealed stenosis of the venous anastomosis and axillary vein.A percutaneous transluminal angioplasty was performed to treat the stenosis.The event of thrombosis was considered resolved and the subject was discharged from the hospital the same day.
Additional Manufacturer Narrative
H10: 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.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: 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: 9959285
• Report Number: 2020394-2020-02667
• Device Sequence Number: 2437671
• 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,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 03/23/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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; ALFACALCIDOL; ALFACALCIDOL; AMLODIPINE; AMLODIPINE; ATORVASTATIN; ATORVASTATIN; BISOPROLOL; BISOPROLOL; DOXAZOSIN; DOXAZOSIN; ESOMEPRAZOLE; ESOMEPRAZOLE; FUROSEMIDE; FUROSEMIDE; HUMAN INSULIN; HUMAN INSULIN; INSULIN GLARGINE; INSULIN GLARGINE; LEVOTHYROXINE; LEVOTHYROXINE; METOPROLOL; METOPROLOL; NITRENDIPINE; NITRENDIPINE; ACETYLSALICYLIC ACID; ALFACALCIDOL; AMLODIPINE; ATORVASTATIN; BISOPROLOL; DOXAZOSIN; ESOMEPRAZOLE; FUROSEMIDE; HUMAN INSULIN; INSULIN GLARGINE; LEVOTHYROXINE; METOPROLOL; NITRENDIPINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61