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

Catalog Number ZVM08120

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified in d2 and g4.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was not available for evaluation and no photos were provided for review.Based on the information available and as the sample was not provided for evaluation, the investigation is closed with inconclusive result.A definite root cause of the reported incident cannot be identified.Labeling review: relevant labeling supplied with this product was reviewed.The reported issue and potential factors were found addressed.E.G., 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".Regarding precautions, the instructions for use states: "take care to avoid unnecessary handling, which may kink or damage the delivery system.Do not use if device is kinked".Regarding general warnings, 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".Regarding accessories the instructions for use states: "in addition to the e-luminexx¿ vascular stent, the following standard materials may also be required to facilitate delivery and deployment of the e-luminexx¿ vascular stent: 8 f (2.67 mm) or larger guiding catheter or 6 f (2.0 mm) or larger introducer sheath; 0.035 inch (0.89 mm) diameter guidewire".H10: d4 (expiration date: 10/2026).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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure in the iliac lesion via the contralateral approach, the stent allegedly kinked.It was further reported that the stent allegedly could not pass through the lesion.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: 18872289
• MDR Text Key: 337303384
• Report Number: 9681442-2024-00036
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147012
• UDI-Public: (01)00801741147012
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM08120
• Device Lot Number: ANHX0555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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