MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO BALLOON EXPANDABLE STENT

Model Number	EV07261CD
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 11/2018, manufacturing date: 04/2017.
Event or Problem Description
It was reported through the results of a clinical trial that approximately six months post deployment of a balloon expandable stent in the right superficial femoral artery, duplex ultrasound demonstrated in-stent restenosis in the target lesion.Approximately eight months post stent deployment, duplex ultrasound demonstrated the target lesion was occluded.The current status of the patient is unknown.
Event or Problem Description
It was reported through the results of a clinical trial that approximately six months post deployment of a balloon expandable stent in the right superficial femoral artery, duplex ultrasound demonstrated in-stent restenosis in the target lesion.Approximately eight months post stent deployment, duplex ultrasound demonstrated the target lesion was occluded.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Investigation summary: the investigation is inconclusive for the reported occlusion, as the device was not returned for evaluation.The definitive root cause for the reported occlusion could not be determined based upon available information.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.(expiry date: 11/2018), (manufacturing date: 04/2017).

• Brand Name: VALEO BALLOON EXPANDABLE STENT
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8072366
• Report Number: 2020394-2018-02031
• Device Sequence Number: 2153806
• Product Code: FGE
• UDI-Device Identifier: 00801741000737
• UDI-Public: (01)00801741000737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: EV07261CD
• Device Catalogue Number: EV07361CD
• Device Lot Number: GFBQ3805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR