MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Catalog Number UNK FLUENCY

Device Problem Occlusion Within Device (1423)

Patient Problem Stenosis (2263)

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 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 Description

It was reported that an alleged in-stent restenosis was identified at the proximal cephalic arch approximately 4 years post stent placement procedure.Reportedly, extravasation of contrast was visible and therefore further angioplasty was performed and another covered stent was successfully deployed.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7340117
• MDR Text Key: 102436260
• Report Number: 2020394-2018-00232
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 108