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

Catalog Number ZVM06030

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.There was no patient involvement; therefore, no patient details were provided to bard.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.

Event Description

It was reported that the delivery system got stuck on a 0.035 inch guide wire prior entering in the patient.The delivery system was removed together with the guide wire.Reportedly, the system had been flushed well prior to use.There was no patient involvement.

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.On the basis of the evaluation of the returned device, the reported event could not be confirmed.A patency test was performed with both a non-hydrophilic 0.035" guide wire and the hydrophilic-coated 0.035" guide wire returned by the customer.Both guide wires could be passed through the delivery system without resistance.In addition, the device could be flushed without issue.For this reason, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.Improper flushing of the device prior to use may be a potential factor to this type of event.Furthermore, a hydrophilic-coated guide wire can become stuck in the system if not kept wet throughout use.In this case, a hydrophilic-coated guide wire was used.On the basis of the evaluation of the returned sample and the information available, a definite root cause for the reported event could not be determined.The ifu states: "prior to inserting the delivery catheter over the guide wire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter." and "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." also the ifu indicates that the e-luminexx vascular stent is only compatible with a 0.035" (0.89 mm) guide wire.

Event Description

It was reported that the delivery system got stuck on a 0.035 inch guide wire prior to entering the patient.The delivery system was removed together with the guide wire.Reportedly, the system had been flushed well prior to use.There was no patient involvement.

• 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6236192
• MDR Text Key: 64257449
• Report Number: 9681442-2017-00012
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: ZVM06030
• Device Lot Number: ANAT1370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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