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

Catalog Number ZVL12120

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 12/12/2023

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 device has not been returned to the manufacturer for evaluation.However, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2024) 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.

Event Description

It was reported that during a stent placement procedure in right femoral vein, the stent allegedly could not release properly and allegedly stuck in the delivery system.It was further reported that the stent delivery rod was allegedly found to have a bend after removal.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 returned for evaluation.Two photos and a video clip were provided.However, the photos and video provided rather indicate a difficult to advance the device over a guidewire; no indication for the reported impossibility to deploy the stent or a deformation of a component could be identified.Based on information available, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.The intended placement of the device to treat iliac vein compression syndrome indicates off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general warnings, the instructions for use states that "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 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".Regarding accessories, the instructions for use states "the bard safer 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire 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.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: 01/2024).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 in the iliac vein via the right femoral vein, the stent allegedly could not be released properly and allegedly got stuck in the delivery system.It was further reported that the stent delivery rod was allegedly found to have a bent after removal.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: 18418536
• MDR Text Key: 331599441
• Report Number: 9681442-2023-00415
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146534
• UDI-Public: (01)00801741146534
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVL12120
• Device Lot Number: ANFN1184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• 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