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

Catalog Number EX061503CS

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

It was reported that during a vascular stent deployment procedure in the sfa, when loading the deployment system on the guide wire, the deployment system appeared to have a wider gap than expected at the distal section on the silver portion.There was no attempt to deploy the stent.A new vascular stent was then prepped and deployed successfully to complete the procedure.There is no reported patient injury.

Manufacturer Narrative

The event is currently under investigation.The device history records are being reviewed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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 revealed that the stent was fully loaded in the system.No tip to sheath gap was visible.A part of an additional catheter was found stuck in the inner lumen of the system protruding the distal tip.An additional device used in the case was returned with a detached part of the distal inner catheter.A patency test with a device compatible guide wire could be performed successfully.Potential contributing factors to the reported event have been evaluated.As the reported event was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.The reported event may be use-related, as a previously detached catheter remaining on the guide wire can cause patency problems.Reportedly, several devices were used in this procedure.Based on the information available, a definite root cause 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." also the ifu states: "advance the stent system over the 0.035¿ diameter guide wire through the sheath introducer" and "if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.".

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: NIP
• 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: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4821048
• MDR Text Key: 18036074
• Report Number: 9681442-2015-00059
• 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
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANYJ0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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 Age: 63 YR
• Patient Weight: 82