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

Catalog Number ZVL08100

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 11/27/2023

Event Type  malfunction  

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.However, images were provided for review.The investigation of the reported event is currently underway.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.

Event Description

It was reported that during a stent placement procedure for abdominal aorta stenosis via left popliteal artery pathway, the stent was allegedly broken.The procedure was completed 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: the stent delivery system was not returned for evaluation but photos were provided showing a deformed placed stent which leads to confirmed results.A closer description of the strut structure around the deformed area wasn't possible due to the poor resolution of the photos.It was reported that there were no serious twists and turns during conveying the delivery system, there was no significant calcification of the vessel and pre-dilatation was performed.Based on evaluation of the provided photos, the investigation is closed with confirmed result for material deformation of the stent.A definite root cause of the reported incident can not be identified.The placement of this stent at the junction of the iliac artery and the abdominal aorta 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 use 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: b5, d4 (expiration date: 05/2026), h6 (device).H11: h6 (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.H3 other text: device not returned.

Event Description

It was reported that during a stent placement procedure at the junction of the iliac artery and the abdominal aorta, via the left popliteal artery pathway, the stent was allegedly broken.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: 18343718
• MDR Text Key: 330706428
• Report Number: 9681442-2023-00399
• 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,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: ANHS2846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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