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

Catalog Number ZVL14120

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

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent handle allegedly falls apart.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4: (expiry date: 01/2025).H11: section a: through f: the information provide 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.

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: the stent delivery system was returned for evaluation.The stent was deployed and missing; a damage inside packaging cannot be reproduced, the condition of the sample does not match the complaint given by the customer which leads to inconclusive results.Provided photos show the performaxx handgrip still intact while the stent is completely deployed and missing and the t-luer adapter is detached from the slider.It was reported that the damage was found before use, the sample was in used condition with fully deployed stent and this doesn't match the reported event.Therefore, based on provided photos and evaluation of the returned sample, the investigation was closed with inconclusive results.A definite root cause for the reported event could not be determined.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 "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".H10: d4 (expiration date: 01/2025), g3.H11: b5, h6 (patient, method, result, conclusion).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.

Event Description

It was reported that during preparation of a stent placement procedure in the iliac artery lesion, upon opening the package, the stent handle was allegedly found to be broken and fell apart.There was no patient contact.

• 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: 19039491
• MDR Text Key: 339372784
• Report Number: 9681442-2024-00067
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146619
• UDI-Public: (01)00801741146619
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVL14120
• Device Lot Number: ANGN3591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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