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

Catalog Number EX071503C

Device Problems Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2011

Event Type  Injury  

Event Description

It was reported that the vascular stent was found to be twisted in the middle section one month post implantation in the sfa.The stent had been placed in overlap with another stent.An additional stent was placed inside the twisted 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 21 cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under #p070014.As the lot number of the subject device was not provided, a device history record review could not be performed.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 images provided, the reported stent twisting could be confirmed.Two stents were placed in overlapping technique and the proximal stent showed a constriction in the proximal part.The images also document the successful treatment of the patient with additional pta and stenting.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations for 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 product 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; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4337797
• MDR Text Key: 5201687
• Report Number: 9681442-2014-00147
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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: 11/10/2014

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: Health Professional
• Device Catalogue Number: EX071503C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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