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

Catalog Number	EX061503CS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
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 was unable to provide further patient details.
Event or Problem Description
It was reported that during a stenting procedure for treatment of a moderate to severe narrowed lesion with very hard calcified plaque in the proximal sfa, upon deployment imaging demonstrated the stent to be appeared narrowed in the mid portion just below the heavily calcified proximal sfa plaque.Magnified images demonstrated the stent to be apparently twisted upon itself.Several attempts were made to open the narrowed/twisted stent segment by using different balloon catheters and guide wires.Finally, a stent graft was implanted inside the previously placed stent across the entire lesion and post-dilated.Follow-up imaging demonstrated the stent graft to be widely patent with only a mild narrowing in the mid portion, with normal distal run-off.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.There is no indication for a manufacturing-related failure.The images provided confirm the reported twisting of the stent in the middle section.During the evaluation of the returned delivery system, no device deficiency was found which may have led to a stent twisting during deployment.Potential factors that may have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The twisting of this kind of stent can 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.In this case, the lesion was reported to be moderate to severe with very hard calcified plaque.Reportedly, the lesion had been pre-dilated.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct application of the device.

• Brand Name: LIFESTENT XL VASCULAR AND BILIARY STENT
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5573703
• Report Number: 9681442-2016-00102
• Device Sequence Number: 257637
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296(17)160714(10)ANYG1579
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P070014/S048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2016

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: 07/14/2016
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANYG1579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 06/20/2016
• 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: 66 YR