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

Catalog Number EX061703C

Device Problems Fracture (1260); Occlusion Within Device (1423); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problem Occlusion (1984)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported that 15 days post implantation of the vascular stent in the sfa, the stent was found to be fractured and occluded.A pta was performed and an additional stent was placed inside the fractured stent.No patient injury was reported.

Manufacturer Narrative

Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under #p070014.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.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 was returned.On the basis of the evaluation of the images provided, a stent fracture could not be identified as the single stent struts were not visible due to the poor resolution of the images.However, the outer shape of the stent leads to the conclusion that the stent is twisted.Potential factors that could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The 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 the twisting of a stent in this region.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 VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; 9681442; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4337835
• MDR Text Key: 5202251
• Report Number: 9681442-2014-00148
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: EX061703C
• Device Lot Number: ANXH3645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Patient Age: 63 YR
• Patient Weight: 68