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

Catalog Number EX061703C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

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 any patient or procedural details to date.

Event Description

It was reported that the vascular stent was deployed in the femoral-popliteal segment for treatment of a moderate stenosis and it was compressed distally.There was no reported patient injury.

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 and no image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported stent compression may have been caused by an irregular stent placement.An unintended movement of the delivery system or excessive compression of the outer catheter during deployment may result in an irregular stent placement.Also a challenging stent placement site as well as tortuous and/or calcified vessel anatomy may contribute to an irregular stent placement.In this case, no anatomical or procedural details were provided.As reported, the lesion had not been pre-dilated.An insufficient pre-dilation of the lesion may be another contributing factor to the reported event.On the basis of the information available, a definitive root cause for the reported complaint could not be determined.The ifu supplied with this device sufficiently describes the correct deployment of the stent.

Event Description

It was reported that the vascular stent was deployed in the femoral-popliteal segment for treatment of a moderate stenosis and it was compressed distally.There was no reported patient injury.

• 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: 5784782
• MDR Text Key: 49294441
• Report Number: 9681442-2016-00196
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: EX061703C
• Device Lot Number: ANZI2976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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