MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR AND BILIARY STENT SYSTEM

Catalog Number VIUS08080

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that post placement in the right external iliac vein, the stent was found to be longer than indicated on the product labeling.The stent allegedly measured 100 mm whereas the labeling indicates a stent length of 80 mm.No patient injury was reported.

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 was returned.On the basis of the image provided, the reported event could not be reproduced.The stent strut structure is not visible on the images and the stent length could not be determined due to the position of the radiopaque marker used by the customer and the poor image resolution.No indication for a mislabeling of delivery system or stent was found.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.It was reported that allegedly the stent was labeled incorrectly and longer than indicated which could not be confirmed during evaluation.Furthermore, a quality control step for inspection of the correct stent length and stent identification is being performed for each device.Based on the review of the manufacturing records, the device met all specifications.On the basis of the information available and the evaluation of the image, a definitive root cause for the reported complaint could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.The ifu indicates that the stent length is measured without stent markers.Additionally, the ifu explains the expected overall stent length change (from its compressed condition within the catheter) when deployed at the recommended oversizing.Furthermore, the ifu states: "should unusual resistance be felt at any time during the procedure, the entire system should be removed as a single unit.".

Event Description

It was reported that post placement in the right external iliac artery, the stent was found to be longer than indicated on the product labeling.The stent allegedly measured 100 mm whereas the labeling indicates a stent length of 80 mm.No advancement or retraction difficulties were reported.Reportedly, no other stent was required.No patient injury was reported.

• Brand Name: LIFESTAR VASCULAR AND BILIARY STENT SYSTEM
• Type of Device: VASCULAR AND BILIARY 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: 5419162
• MDR Text Key: 37790257
• Report Number: 9681442-2016-00039
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080007/S020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: VIUS08080
• Device Lot Number: ANXL1783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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: 71 YR
• Patient Weight: 78