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

Model Number	ZBM12040
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images and video were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).Device not returned.
Event or Problem Description
It was reported that post stent placement, the tantalum marker was allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 to the manufacturer for evaluation.Image and video was provided which indicates the fracture of the tantalum marker band.Additionally, a radiopaque object was observed to be migrated.Based on evaluation of the x-ray provided, the reported fracture of the placed stent, as well as the migration of the section was confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use sufficiently address the potential risks.The instructions for use states: 'as with all self-expanding nitinol stents, careful attention during stent deployment is warranted to mitigate the potential for movement of the stent.' and 'after stent deployment, carefully withdraw the delivery system from the patient over the guidewire.After removing the delivery system, visually confirm that the entire stent delivery system has been removed.(.) (a) inner catheter (.) outer catheter (.) moving distal marker (.) on outer catheter.' additionally, the instructions for use states: 'maintaining a straight catheter under slight tension during stent deployment is recommended to improve placement accuracy.In regards to post-stent placement, instructions for use stated "post-dilatation of the stent with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." stent fracture was listed as the potential adverse event.In regards to instruction for use: 'the bard e-luminexx biliary stent is indicated for the treatment of biliary strictures resulting from malignant neoplasms.' h10: d4 (expiry date: 01/2022), g3, h6 (device) h11: h6 (method, result, conclusion) 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.Device not returned.
Event or Problem Description
It was reported that post stent placement, the tantalum marker was allegedly fractured.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
• MDR Report Key: 11116231
• Report Number: 9681442-2020-20143
• Device Sequence Number: 3608565
• Product Code: FGE
• UDI-Device Identifier: 04049519010366
• UDI-Public: (01)04049519010366
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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 Model Number: ZBM12040
• Device Catalogue Number: ZBM12040
• Device Lot Number: ANDN0633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 06/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other