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

Model Number	EX061703CS
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	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.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 that one year post implantation of the vascular stent in the distal sfa, an x-ray image demonstrated the stent to be twisted at the level of approximal 12 cm (complete stent length = 17 cm).As reported, the lesion was occluded 100 % and pta was performed for patient treatment.The blood flow is still present before and after the twisted area.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 evaluation of the images provided, the reported stent twisting could be confirmed.The images document an hourglass-shaped deformation proximal to the knee which was identified as stent twisting.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 a twisting of a stent in this region.In this case, the lesion had been pre-dilated and no difficulty occurred during use of the device.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 device sufficiently describes the correct stent placement procedure.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 one year post implantation of the vascular stent in the distal sfa, the stent was found to be twisted on x-ray imaging.As reported, the blood flow is still present up to and behind the twisted area.No additional intervention was performed.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6489300
• Report Number: 9681442-2017-00138
• Device Sequence Number: 19133193
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961(17)170717(10)ANZG1914
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: 07/17/2017
• Device Model Number: EX061703CS
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANZG1914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 07/03/2017
• 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: 39 YR