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

Catalog Number	EX061703CS
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that after successful placement of the vascular stent in the sfa, the delivery system got stuck on the 0.035 inch guide wire during removal.The guide wire and delivery system were removed as one unit.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.On the basis of the condition of the returned device, the reported failure could not be confirmed.A guide wire patency test was performed without issue.No deformation or deficiency of the device was identified.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.This kind of event may be associated with a difficult vessel anatomy.Also insufficient flushing of the device may be a contributing factor to the reported event since the delivery system can become stuck on the guide wire if not kept wet throughout use.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the stent system should not be used" and "flush the inner lumen of the device with saline prior to use".Also the ifu states: "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together.".

• 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: 5428053
• Report Number: 9681442-2016-00044
• Device Sequence Number: 13552567
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961(17)170116(10)ANZA1507
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014/S049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2017
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANZA1507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68