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

Catalog Number EX060603CS

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported that after successful placement of the vascular stent in the sfa, the delivery system snagged on the stent during removal, causing the stent to move and the distal tip of the delivery system to detach.A surgical intervention was performed to remove both the stent and the detached tip.The pt was reported to be stable post procedure.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing an inspection of this product and the product was found to have met all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample and no images were provided.Therefore, the reported event could not be reproduced.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.This kind of event may be associated with an irregular stent placement leading to stent struts that extend into the lumen causing an increased risk of entrapment.Also a difficult vessel anatomy, a challenging placement site, an inadvertent movement of the hand or incorrect holding of the delivery system during stent deployment may lead to an irregular stent placement.In this case, the vessel was reported to be heavily calcified.On the basis of the info available, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct deployment of the stent.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe ; GM
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4294428
• MDR Text Key: 5054679
• Report Number: 9681442-2014-00144
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

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
• Device Operator: Other
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: EX060603CS
• Device Lot Number: ANXB1084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention