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

Catalog Number EX061703CS

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

It was reported that during deployment of the vascular stent in the sfa, the stent could not be released any further after it had begun to deploy.The device was then retracted without issue.No pt injury was reported.Upon sample eval, the stent was found to be partially released.

Manufacturer Narrative

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

Manufacturer Narrative

The device history records have been reviewed with a special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing related failure.During the evaluation of the returned device the stent was found to be partially deployed.During further investigation the stent could be released successfully without issue by using both deployment methods.No device deficiency was found.Therefore, the reported event could not be reproduced.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigation of similar complaints have been reviewed.A difficult vessel anatomy or challenging placement site may lead to high friction during the attempt to release the stent based on the information available and the evaluation of the returned sample, a definite root cause to the reported event could not be determined.The ifu states " if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.".

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4752270
• MDR Text Key: 18029700
• Report Number: 9681442-2015-00037
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANXH0594
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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