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

Model Number	ZBM14040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2023).Device pending return.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly deployed prematurely.Additional intervention was required to recover the stent and the procedure was completed using another device.The current status of the patient is unknown.
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 device was not available for evaluation nor any images.Based on the information available, the investigation was closed with inconclusive result.Based upon the available information a definitive root cause could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use sufficiently address the potential risk of a damaged product.The instructions for use states: "verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use.¿ furthermore, the instructions for use states: "if the red safety clip has been removed or becomes inadvertently detached from the grip, do not use the device." regarding the potential factor of high friction forces between the guide wire and the inner catheter, the instructions for use states: "prior to inserting the delivery catheter over the guide wire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter".H10: d4 (expiry date: 08/2023), g3 h11: h6 (result and conclusion) 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly deployed prematurely.Additional intervention was required to recover the stent and the procedure was completed using another device.The current status of the patient is unknown.

• 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: 11222467
• Report Number: 9681442-2020-20174
• Device Sequence Number: 11701343
• Product Code: FGE
• UDI-Device Identifier: 04049519010434
• UDI-Public: (01)04049519010434
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZBM14040
• Device Catalogue Number: ZBM14040
• Device Lot Number: ANEV2801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: Required Intervention