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

Catalog Number	EX061503CS
Medical Device Problem Codes	Material Torqued (2980); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
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 the stent appeared to be twisted after deployment in a pre-dilated lesion of the right sfa.As reported, there were no issues during the placement of the stent and the stent delivery system was in a straight section during deployment.An additional stent was placed to realign the twisted stent and complete the procedure.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.No sample was returned.On the basis of the images provided, the reported stent twisting could be confirmed as the stent shows an hourglass shaped section.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.A twisting of this kind of stent may be caused by interactions of various use-related and anatomical factors with the given stent design.Also various physical forces including individual patient factors may contribute to the twisting of a stent in this region.A not performed pre-dilation may be another potential contributing factor.In this case, the lesion had been pre-dilated and the stent was placed in a straight section of lumen.As reported, the delivery system was not twisted during stent deployment.On the basis of the information available and the evaluation of the images provided, a definite root cause for the reported event could not be determined.The ifu supplied with this dev ice sufficiently describes the correct deployment of the stent.Also the ifu states that pre-dilation of the lesion should be performed by using standard techniques and post stent expansion with a pta catheter is recommended.
Event or Problem Description
It was reported that the stent appeared to be twisted after deployment in a pre-dilated lesion of the right sfa.As reported, there were no issues during the placement of the stent and the stent delivery system was in a straight section during deployment.An additional stent was placed to realign the twisted stent and complete the procedure.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: 6345692
• Report Number: 9681442-2017-00058
• Device Sequence Number: 1576828
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296(17)180812(10)ANAV1727
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 08/12/2018
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANAV1727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 04/05/2017
• 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: 77 YR
• Patient Weight: 97