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

Model Number	EX071203CS
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported during deployment in proximal common iliac via bilateral groin, the stent was allegedly jumped into distal aorta.It was further reported that patient was scheduled for surgery to retrieve the stent.
Additional Manufacturer Narrative
Manufacturing review: the lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: the physical catheter sample was returned for evaluation, however, an indication for a difficult deployment respectively a stent jumping could not be found.Images documenting the misplaced stent or movies documenting the stent jumping have not been provided.The alleged stent jumping could not be re produced which led to an inconclusive evaluation result.An indication for a process related issue could not be found.Based on the information available the investigation will be closed with inconclusive result.A definite root cause could not be identified.The reported application represents an off label use of the device.Labeling review: in reviewing the relevant ifu for this product the potential issue was found addressed.The ifu states: 'confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position (.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1 cm minimum (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end (.) deployment of the stent is complete when the proximal stent end apposes the vessel wall and the sheath radiopaque zone is proximal to the proximal end of the stent.' malposition was found mentioned as an adverse event that may occur.The ifu further states: 'the lifestent xl vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and popliteal artery (.)'.
Event or Problem Description
It was reported that during deployment in the proximal common iliac via bilateral groin access, the stent allegedly jumped into the distal aorta.It was further reported that the patient was scheduled for surgery to retrieve the stent.

• Brand Name: LIFESTENT BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8035515
• Report Number: 9681442-2018-00192
• Device Sequence Number: 1464189
• Product Code: FGE
• UDI-Device Identifier: 04049519001319
• UDI-Public: (01)04049519001319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: 05/25/2020
• Device Model Number: EX071203CS
• Device Catalogue Number: EX071203CS
• Device Lot Number: ANCS3097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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