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

Catalog Number	EX061503CS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during a stenting procedure of the sfa, the stent fractured immediately during deployment.Reportedly, the lesion was post-dilated and two additional stents were placed through the fracture to complete the procedure successfully.There was no reported patient injury.
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.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned delivery system, the reported stent fracture could not be confirmed.The stent was not returned as it remains implanted.No images were provided for evaluation.No defect or deficiency of the delivery system was found which may have led to difficulties during stent deployment and to the alleged stent fracture.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre- or post-dilation, highly calcified vessels, the patient's condition or the vessel anatomy may result in an irregular stent placement and subsequent stent fracture.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be identified.The ifu supplied with this product sufficiently describes the correct application of the device.Also the ifu indicates that stent fracture is a potential adverse event that may occur.
Event or Problem Description
It was reported that during a stenting procedure of the sfa, the stent fractured immediately during deployment.Reportedly, the lesion was post-dilated and two additional stents were placed through the fracture to complete the procedure successfully.There was no reported patient injury.

• 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: 6131943
• Report Number: 9681442-2016-00308
• Device Sequence Number: 223817
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296(17)180318(10)ANAQ2639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2016

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 Expiration Date: 03/18/2018
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANAQ2639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/28/2016
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 73