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

Model Number	40S06
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/09/2018
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one year six months post vascular graft placement in the upper arm, the subject experienced stenosis within the graft anastomosis and was admitted to the hospital.Reportedly, angioplasty was performed and follow-up imaging demonstrated no stenosis within the graft anastomosis.The event was considered resolved and the subject was discharged from the hospital the following day.
Additional Manufacturer Narrative
A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for obstruction within device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one year six months post vascular graft placement in the upper arm, the subject experienced stenosis within the graft anastomosis and was admitted to the hospital.Reportedly, angioplasty was performed and follow-up imaging demonstrated no stenosis within the graft anastomosis.The event was considered resolved and the subject was discharged from the hospital the following day.It was reported through the results of a clinical trial that approximately one year post vascular graft placement, the subject experienced stenosis of vascular access.Approximately one year six months post vascular graft placement, the subject experienced stenosis of vascular access.

• Brand Name: IMPRA EPTFE 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: 7943266
• Report Number: 2020394-2018-01870
• Device Sequence Number: 941018
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 09/17/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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, PENTOXIFYLLINE, PANTOPRAZOLE; ACETYLSALICYLIC ACID, PENTOXIFYLLINE, PANTOPRAZOLE; AMLODIPINE, METOPROLOL, FUROSEMIDE, ATORVASTATIN; AMLODIPINE, METOPROLOL, FUROSEMIDE, ATORVASTATIN; CLOPIDOGREL, CALCIUM ACETATE, ALFACALCIDOL; CLOPIDOGREL, CALCIUM ACETATE, ALFACALCIDOL; ISOPHANE INSULIN, INSULIN LISPRO, RAMIPRIL; ISOPHANE INSULIN, INSULIN LISPRO, RAMIPRIL; TRIMEBUTINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 66