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

Catalog Number	ZBM10040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The return of the sample is pending.The investigation of the reported event is currently underway.D2b (fge; nio).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.
Event or Problem Description
On (b)(6) 2026, a patient underwent stent placement procedure using e luminexx.During the deployment procedure the stent jumped and missed the targeted stenotic area in upper extremity.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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 and photos were not provided which leads to inconclusive results.In this case, only very limited information was provided about the event.Based on the provided information and as neither sample nor photos were provided for evaluation, the investigation is closed with a inconclusive results.A definitive root cause for the reported incident could not be identified.Labelling review: in reviewing the relevant labeling it was found that the instructions for use instruction for use (ifu) sufficiently address the potential risks the ifu contains a table describing the relationship between unconstrained stent diameter and reference lumen vessel diameter with regards to stent placement precautions the ifu states the stent experiences minimal length changes during deployment to maximize stent placement accuracy slowly and deliberately deploy the distal portion of the stent until you have visual confirmation of wall apposition before steadily deploying the remaining length of the stent regarding accessories the ifu state the bard safe 6f delivery system requires a minimum 6f introducer sheath insert a 0035 inch 089 mm guidewire regarding potential complications the ifu states stent malposition failure to deliver the stent to the intended site may occur d2b (fge; nio), g3, h6 (method, result, conclusion) 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 or Problem Description
On (b)(6) 2026, a patient underwent stent placement procedure using e luminexx.During the deployment procedure the stent jumped and missed the targeted stenotic area in upper extremity.There was no reported patient injury.

• Brand Name: E-LUMINEXX BILIARY STENT
• Common Device Name: BILIARY 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: 24542893
• Report Number: 9681442-2026-00044
• Device Sequence Number: 18451521
• Product Code: FGE
• UDI-Device Identifier: 04049519009490
• UDI-Public: (01)04049519009490(17)280819(10)ANKV1655
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ZBM10040
• Device Lot Number: ANKV1655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown