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

Catalog Number EX061703C

Device Problems Obstruction of Flow (2423); Material Torqued (2980); Material Twisted/Bent (2981)

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

Event Date 09/17/2014

Event Type  Injury  

Event Description

It was reported that the vascular stent was found to be constricted two days post implantation in a femoral graft.Pta was performed unsuccessfully.An additional stent was placed to treat the patient.No patient injury was reported.

Manufacturer Narrative

Although this product is not sold in the u.S.This event is being reported under regulations 21 cfr 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.The evaluation of the image provided confirmed a constriction of the stent in the middle section.The strut material accumulation and deformation indicates a stent twisting.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigation of similar complaints have been reviewed.A 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.The reported application represents an of-label use of the device, which is considered another contributing factor to the reported event.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu supplied with the device sufficiently describes the correct deployment of the stent.The ifu states that the lifestent vascular stent is indicated for primary stenting of de-novo or restenotic lesions of peripheral arteries.The safety and effectiveness of the device for a treatment as described has not be established.

• Brand Name: LIFESTENT VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4176423
• MDR Text Key: 5090386
• Report Number: 9681442-2014-00135
• 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: 09/17/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: EX061703C
• Device Lot Number: ANXE0981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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: 45 YR