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

Catalog Number ZVL08100

Device Problems Fracture (1260); Migration (4003)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported that approximately one year eleven months and six days post stent placement procedure, the proximal stent mark points was allegedly in the atrium.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: the sample was not returned for evaluation.Provided videos show two stent ends over a guidewire with both ends are having the marker section.One stent end has three x-ray markers and the other stent end has four which leads to confirmed results for stent fracture and migration of the fracture piece.A closer description of the strut structure around the deformed area wasn't possible due to the poor resolution.It was reported that no problems with the stent structure were observed after the stent was released.Based on evaluation of the provided videos, the investigation is closed with confirmed result for fracture of the stent and migration of the fractured piece.A definite root cause of the reported incident cannot be identified.The placement of this stent in a tips procedure represent an off-label use.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Holding and handling of the system during deployment was found addressed; in particular the instructions for use state: 'prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.During stent deployment, the entire length of the catheter system should be kept as straight as possible.Maintaining a straight catheter under slight tension during stent deployment is recommended to improve placement accuracy'.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".The instructions for us indicates 'stent fracture' as a malfunction and adverse event.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 (expiry date: 07/2024).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.

• 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: 18561126
• MDR Text Key: 333445396
• Report Number: 9681442-2024-00009
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146282
• UDI-Public: (01)00801741146282
• 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: 01/04/2024

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: ZVL08100
• Device Lot Number: ANFU1165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/23/2024
• 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