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 Unspecified Infection (1930); Sepsis (2067)

Event Date 07/10/2019

Event Type  Injury  

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 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 Description

It was reported through the results of a clinical trial that approximately 735 days post implantation, patient experienced infection as the patient was hospitalized and discharged one day post hospitalization with ongoing result.It was further reported that the patient was hospitalized 756 days post index procedure and the subject developed sepsis and underwent foot incision and removal of study access.The patient was discharged 54 days post admission day.

• 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9445986
• MDR Text Key: 170110096
• Report Number: 2020394-2019-05403
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/14/2019
• 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; AMLODIPINE; BISOPROLOL FUMARATE; FOLIC ACID; FUROSEMIDE; HYDROXYCHLOROQUINE; INSULIN DETEMIR; INSULIN LISPRO PROTAMINE SUSPENSION; PANTOPRAZOLE; PREDNISONE; TELMISARTAN; THIAMAZOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 60