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

Catalog Number EX061703C

Device Problems Occlusion Within Device (1423); Dent in Material (2526); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problems Occlusion (1984); Reocclusion (1985); Claudication (2550); Vascular System (Circulation), Impaired (2572)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide further patient details.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 # (b)(4).

Event Description

It was reported that the patient complained about claudication accompanied with pale toes at the index limb since 5 days.The angiographic overview showed a complete occlusion of the sfa and two new indents of the implanted vascular stents.A surgical intervention (bypass) is required for treatment.This is the same patient as reported in medwatch report # 9681442-2016-00150.

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.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.X-ray images were provided for evaluation.The evaluation of the images confirmed that two stents had been placed in overlapping technique.Two shorter stents were placed afterwards inside these stents for treatment of previous irregularities of the stents.Twisted sections in both stents respectively distal to the shorter stents can be confirmed.Potential factors that could have led or contributed to the reported event have been evaluated.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.In this case, no issues during the initial stent placement were reported.Reportedly, the lesion was pre and post-dilated.On the basis of the information available and the evaluation of the images provided, 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.The ifu also indicates that post stent expansion with a pta catheter is recommended and pre-dilation of the lesion should be performed by using standard techniques.

Event Description

It was reported that the patient complained about claudication accompanied with pale toes at the index limb five months post implantation of two vascular stents without any irregularities in november 2015.An angiographic overview showed a complete occlusion of the sfa and two indents of the implanted stents.A surgical intervention (bypass) was performed one month later for treatment.This is the same patient as reported in medwatch report # 9681442-2016-00150.

• Brand Name: LIFESTENT XL VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5694982
• MDR Text Key: 46415616
• Report Number: 9681442-2016-00149
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EX061703C
• Device Lot Number: ANZF2962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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: 71 YR