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

Catalog Number EX062502L

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Occlusion (1984); Reocclusion (1985); Pain (1994)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The lot history records are being reviewed.The event is currently under investigation.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.

Event Description

It was reported that approximately one year post implantation of the vascular stent for treatment of an occlusion in the left middle to distal sfa and popliteal artery, a re-occlusion was detected.A balloon dilation was performed for treatment.There was no reported patient injury.

Manufacturer Narrative

The device 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.No sample was returned.On the basis of the images provided, it can confirmed that the stent implanted in the sfa was found to be occluded 10 months post placement.The images also confirm that a balloon dilation was performed for patient treatment and that the blood flow was improved after treatment.The stent was found to be in good condition with a regular strut pattern; therefore, no indication for a relation between the stent and the vessel occlusion could be identified.Potential factors that could have led or contributed to the reported event have been evaluated.Previously reported similar complaints have been reviewed.Restenosis of the treated vessel may occur as a result of various factors.In this case, no indication for a device relation could be identified.The general condition of the patient, the medication after stent placement as well as the vessel anatomy may contribute to the reported event.In this case, the stent could be successfully implanted, the lesion was pre and post-dilated, and no irregular strut pattern was identified.On the basis of the information provided, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the potential risk by stating that arterial occlusion / restenosis of the treated vessel is a potential adverse event that may occur.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• 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: 5660125
• MDR Text Key: 45333018
• Report Number: 9681442-2016-00131
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: EX062502L
• Device Lot Number: ANYJ1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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: 82 YR
• Patient Weight: 63