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

Catalog Number ZVL10040

Device Problems Positioning Failure (1158); Flushing Problem (1252); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Although this product is not sold in the u.S., this event is being reported under regulation 21 cfr 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 during a tips procedure via access through the ivc, the delivery system could not be flushed through the distal luer port.The physician tried to deploy the vascular stent by activating the trigger mechanism without success.The delivery system was removed and another stent was used to complete the procedure.There was no reported patient injury.

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 stent could not be deployed by using the trigger mechanism due to the detachment of a force transmitting component in the grip section.During the performed function test, the stent could be released by using the pin and pull technique and the system could be flushed through both ports without issue.For this reason, the reported flushing problem could not be confirmed.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported flushing difficulties may be caused by system damage during transport, unpacking or handling.However, during evaluation the system could be flushed and the stent could be released easily indicating that the flushing lumen was not obstructed.The detachment of the t-luer adapter may be caused by rough handling of the device during shipping or storage.The t-luer adapter also may become detached during preparation of the device (e.G.During flushing).Increased release force may occur as a consequence of insufficient flushing, a difficult vessel anatomy, rough handling or device damage.In this case, the device was intended to be used during a tips procedure which represents an off-label use and is considered another contributing factor to the reported event.On the basis of the information available and the sample evaluation, a definite root cause for the reported event could not be determined.The ifu states: "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." also the ifu states: "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." and "flushing eliminates air bubbles from the inner catheter lumen and lubricates the surface between the inner and outer catheters (.).During system flushing, do not use the system if fluid is not observed exiting the catheter at the distal tip." furthermore, the ifu indicates that the device is intended for use in the iliac and femoral arteries.

Event Description

It was reported that during a tips procedure via access through the ivc, the delivery system could not be flushed through the distal luer port.The physician tried to deploy the vascular stent by activating the trigger mechanism without success.The delivery system was removed and another stent was used to complete the procedure.There was no reported patient injury.

• 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: 5986388
• MDR Text Key: 55884624
• Report Number: 9681442-2016-00255
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: ZVL10040
• Device Lot Number: ANZC0622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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: 35 YR
• Patient Weight: 50