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

Catalog Number EX071503CS

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

It was reported that after successful deployment of the vascular stent in the sfa, the delivery system became stuck on the guide wire during retraction.The delivery system and the guide wire were removed as one unit without issues.A new guide wire was advanced to the lesion site and a post-dilation was performed to fully expand the vascular stent and successfully complete the procedure.There was no reported pt injury.

Manufacturer Narrative

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

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.There is no indication for a manufacturing-related failure.The evaluation of the returned device confirmed that the guide wire was stuck on the delivery system.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.This kind of event may be associated with the vessel anatomy and/or insufficient flushing of the device since the delivery system can become stuck if not kept wet during use.In this case, the vessel was reported to be slightly calcified.Based on the information available, a definite root cause for the reported event could not be determined.The ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the stent system should not be used." and "flush the inner lumen of the device with saline prior to use." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together.".

• 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: 4804571
• MDR Text Key: 5896368
• Report Number: 9681442-2015-00052
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: EX071503CS
• Device Lot Number: ANXK2675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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 Age: 60 YR
• Patient Weight: 78