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

Catalog Number ZVL14080

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

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent allegedly cannot be released.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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: a physical sample was returned for evaluation.During evaluation, the t-luer adapter was detached from the slider which made a successful deployment using the trigger impossible.The stent was still loaded in the delivery catheter and could be deployed during deployment test using the conventional method.Photos / video were provided with the stent still loaded in the catheter, the t-luer adapter was detached from the slider.It was reported that a 0.035" guidewire with 7f introducer were used, the tracking vessel was neither tortuous nor calcified and the lesion was predilated.The failure to deploy using the trigger is considered to have resulted from the detachment of the t-luer adapter from the slider.Based on provided photos and video, and evaluation of the returned sample, the investigation was closed with confirmed results for detachment, and the subsequent failure to deploy using the trigger is considered a cascading event.A definite root cause for the reported event could not be determined.The intended placement of the device to treat ivcs 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.Regarding general warning, the instructions for use 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 "visually inspect the e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instructions for use states "the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035-inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guide wire.With regards to general directions, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".With regards to indications for use, the instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".H10: d4 (expiration date: 05/2026) h11: section a through f ¿ the information provided by bd represents all 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.

• 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: 18951334
• MDR Text Key: 338335574
• Report Number: 9681442-2024-00059
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146596
• UDI-Public: (01)00801741146596
• 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: 03/19/2024

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: ZVL14080
• Device Lot Number: ANHS2831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/21/2024
• 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