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

Model Number	EX061703CS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/29/2015
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 twelve months post stent placement in the femoral artery, routine duplex ultrasound demonstrated in-stent stenosis.Routine duplex ultrasound also demonstrated in-stent stenosis during the subject's twenty-four and thirty-six month follow ups.There was no reported intervention performed.The patient completed the study; therefore, the current status of the patient is unknown.
Event or Problem Description
It was reported through the results of a clinical trial that approximately twelve months post stent placement in the femoral artery, routine duplex ultrasound demonstrated in-stent stenosis.Routine duplex ultrasound also demonstrated in-stent stenosis during the subject's twenty-four and thirty-six month follow ups.There was no reported intervention performed.The patient completed the study; therefore, the current status of the patient is unknown.
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.Investigation summary: no sample and no images were provided for evaluation.In this case the lesion was stenosed.However, after pre dilation, stent placement and post dilation, there was no residual stenosis.The stent was implanted without malfunction.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: in reviewing the labeling for this product it was found that the ifu sufficiently addresses the potential risk.The ifu states that 'arterial occlusion/restenosis of the treated vessel' is a potential adverse events that may occur.In regards to repeated pta the ifu states: 'the long-term outcomes following repeat dilatation of endothelialized stents are unknown.' the stent deployment procedure was found to be properly addressed in the ifu.In regards to balloon dilation the ifu states: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' (expiry date: 01/2016), (manufacturing date: 02/2014).

• Brand Name: LIFESTENT VASCULAR STENT
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7839875
• Report Number: 9681442-2018-00156
• Device Sequence Number: 19284711
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: EX061703CS
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANYA2525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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; PLAVIX; PLAVIX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR