MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR AND BILIARY STENT SYSTEM

Model Number	EX061503CS
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.(expiration date: 08/2016), manufacture date: 08/2014.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 five months post stent placement in the distal superficial femoral artery, the subject required additional stent placement with an overlap in the target lesion.The subject was discharged from the hospital approximately two weeks post target lesion re-intervention.Approximately twenty four months post stent placement, x-ray demonstrated stent fracture.The current status of the patient was not provided.
Additional Manufacturer Narrative
Manufacturing review: the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.No additional complaint has been previously reported for this lot number.Investigation summary: images documenting the stent fracture and occlusion have not been provided.The alleged failure could not be re produced which led to an inconclusive evaluation result.In this case moderate calcification was present, the lesion was pre and post dilated, and no irregularitiy during initial stent placement were reported; the deployment was successful with excellent placement accuracy.Heavy calcification of the target vessel, insufficient pre dilation or post dilation as well as overlapping stent placement may be contributing factors.However, based on the information available a definite root cause for the event reported could not be identified.Labeling review: 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.(expiration date: 08/2016), 08/2014, (device).(patient), (method), (conclusions).
Event or Problem Description
It was reported through the results of a clinical trial that approximately five months post stent placement in the distal superficial femoral artery, the subject required additional stent placement with an overlap in the target lesion.The subject was discharged from the hospital approximately two weeks post target lesion re-intervention.Approximately twenty four months post stent placement, x-ray demonstrated stent fracture.The current status of the patient was not provided.

• Brand Name: LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7658861
• Report Number: 9681442-2018-00101
• Device Sequence Number: 10796738
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: EX061503CS
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANYH0706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: ASPIRIN; ASPIRIN; ASPIRIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR