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

Catalog Number ZVL06040

Device Problems Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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: the stent delivery system was returned for evaluation and the stent was still loaded in the delivery system and in place.The delivery system was detached from the slider but however, still secured by the stabilizer.The trigger mechanism was activated and the slider moved proximally by a few mm but the inner catheter was not protruding.During testing on the bench, the stent could be deployed by retraction and pulling.It is considered that the detachment of the t-luer from the slider led to the eventual failure to deploy the stent using the trigger.It was reported that a 0.035" guidewire and 6f sheath were used, there was slight calcification and pre-dilation was performed.Based on analysis of the returned sample, the investigation is closed with confirmed results for detachment and "failure to deploy" is considered to have been a cascading event.A definite root cause of the reported incident can not be identified.The reported indication represents an off label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general directions, the instructions for use states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The instructions for use further 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".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to indications for use, the instructions for use states that the stent is to be used on femoral and iliac arteries.The reported use of the device to treat renal artery stenosis represents an off-label use.Expiry date: 09/2024.

Event Description

It was reported that during a stent placement procedure, the stent allegedly misfired.The procedure was completed using another device.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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15904140
• MDR Text Key: 307275501
• Report Number: 9681442-2022-00347
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146084
• UDI-Public: (01)00801741146084
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2022

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: ZVL06040
• Device Lot Number: ANFW3244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR
• Patient Sex: Female