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

Catalog Number	EX071003CS
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.Not returned.
Event or Problem Description
It was reported that the stent allegedly fractured post deployment in the sfa.The stent remains implanted and no further treatment was performed.No patient injury was reported.
Additional Manufacturer Narrative
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 all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample was returned.Based on the images provided, the reported stent fracture could not be confirmed.Due to the poor resolution of the images, the stent strut structure was not visible.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.An irregular stent placement may contribute to a subsequent stent fracture.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre or post-dilation as well as highly calcified vessels, the patient's condition or the vessel anatomy may result in an irregular stent placement.In this case, it was reported that the anatomy was moderately calcified and that the stent deployed smoothly.On the basis of the information available and the evaluation of the images, a definite root cause for the reported event could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.Also the ifu states that stent fracture is potential adverse event that may occur.

• Brand Name: LIFESTENT XL 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: 5357155
• Report Number: 9681442-2016-00013
• Device Sequence Number: 18853800
• Product Code: NIP
• UDI-Device Identifier: 04049519001302
• UDI-Public: (01)04049519001302(17)170630(10)ANZF3710
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014/S049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EX071003CS
• Device Lot Number: ANZF3710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2016
• Supplement Report FDA Received Date: 03/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 82