MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVM10120

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation.Since the lot number of the subject device has not been provided a device history record review could not be performed.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p080007.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.Not returned.

Event Description

It was reported that two stents were placed into the iliac arteries.Allegedly after the procedure the stents appeared to be different in length size.

Manufacturer Narrative

As the lot number of the subject device was not provided, a device history record review could not be performed.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.Based on the image provided, the reported stent foreshortening could not be confirmed.No irregularity of the stent strut structure could be identified due to the poor resolution of the images.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.Minimal changes in stent length may occur during deployment, as stated in the ifu.Also the stent may become shortened by the attempt of micro adjustments or due to unintentional movements of the handle during placement.Also the anatomical conditions may lead to difficulties in deploying the stent, finally leading to stent foreshortening.In this case, the tracking path and the target anatomy were reported to be tortuous which could be confirmed on the images provided.On the basis of the information available and the images provided, a definitive root cause could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.Furthermore, the ifu states: "once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen." and "visually inspect the bard e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.".

Event Description

It was reported that two stents were placed in both sides of the iliac artery.One of the stents seemed to be shorter than intended post stent implantation.No reported patient injury was reported.

• Brand Name: E-LUMINEXX 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: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5055439
• MDR Text Key: 25350484
• Report Number: 9681442-2015-00147
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM10120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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