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

Catalog Number ZVL08120

Device Problems Break (1069); Premature Activation (1484); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified.(expiry date: 11/2020).

Event Description

It was reported that prior to removing the safety clip, the inner shaft was allegedly detached and extruded from the delivery system.It was further reported that the delivery system was removed without incident and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: based on the investigation of the returned catheter sample a premature deployment or damage could not be confirmed.The sample was found with partially deployed stent, but the safety clip was found removed so that a premature deployment could not be confirmed.During evaluation testing the stent could be easily deployed.In this case system compatible accessories were being used, but the user felt strong resistance when passing the lesion.The lesion was pre dilated.A manufacturing related root cause was considered; however, 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 the specification prior to shipment.Based on the information available a definitive root cause for the reported complaint could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu state: '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'.Regarding accessories ifu state: 'the 6fr delivery system requires a minimum 6f introducer sheath.The delivery system has a soft and flexible catheter tip formed from the outer catheter.The catheter tip is tapered to accommodate a 0.035¿(0.89 mm) guidewire.', and 'do not remove the safety holder until you are ready to deploy the stent.', and 'if the red safety holder has been removed or becomes inadvertently detached from the handle, do not use the device.' regarding damage the ifu state: 'visually inspect the bard e luminexx vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment'.Furthermore, the e-luminexx vascular stent system is indicated for use in the iliac and femoral arteries.H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified in d2 and g5.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that after experiencing difficulty tracking through the common iliac artery to treat the aorta, the inner shaft was allegedly detached and extruded from the delivery system without the healthcare provider (hcp) removing the safety clip.It was further reported that the delivery system was retracted from the patient without incident and another device 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
• MDR Report Key: 9584536
• MDR Text Key: 179116772
• Report Number: 9681442-2019-00258
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146299
• UDI-Public: (01)00801741146299
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

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 Catalogue Number: ZVL08120
• Device Lot Number: ANBY1506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1