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

Model Number 40S06

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 01/26/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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 Description

It was reported through a clinical trial that the subject experienced multiple serious events of thrombosis and stenosis of vascular access.Approximately 1534 days post study conduit placement, the patient was hospitalized due to thrombosis of vascular access and aneurysm of the conduit.Approximately 1535 days post study conduit placement, the subject experienced stenosis and aneurysm of vascular access.The subject underwent a thrombectomy procedure, removal of aneurysm and surgical revision.The event was resolved on the same day and the subject was discharged the following one-day post procedure.The current status of the patient was not provided.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of (b)(6) 2021.The correct g3 date is (b)(6) 2021.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged thrombosis and stenosis of vascular access could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provide by bd represents all 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 Description

It was reported through a clinical trial that the subject experienced multiple serious events of thrombosis and stenosis of vascular access.Approximately 1534 days post study conduit placement, the patient was hospitalized due to thrombosis of vascular access and aneurysm of the conduit.Approximately 1535 days post study conduit placement, the subject experienced stenosis and aneurysm of vascular access.The subject underwent a thrombectomy procedure, removal of aneurysm and surgical revision.The event was resolved on the same day and the subject was discharged the following one-day post procedure.The current status of the patient was not provided.

• Brand Name: IMPRA VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12680728
• MDR Text Key: 277880935
• Report Number: 2020394-2021-01899
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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
• Device Operator: Health Professional
• Device Model Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/07/2021
• Supplement Dates FDA Received: 11/11/2021
• 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
• Treatment: ACETYLSALICYLIC ACID.; ACETYLSALICYLIC ACID.; CALCIUM CARBONATE, BISOPROLOL, AMLODIPINE.; CALCIUM CARBONATE, BISOPROLOL, AMLODIPINE.; FOLIC ACID, OMEPRAZOLE, SIMVASTATIN.; FOLIC ACID, OMEPRAZOLE, SIMVASTATIN.; ACETYLSALICYLIC ACID; CALCIUM CARBONATE, BISOPROLOL, AMLODIPINE; FOLIC ACID, OMEPRAZOLE, SIMVASTATIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White