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

Model Number	ZBM14040
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
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, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2022).
Event or Problem Description
It was reported that during the procedure, the stent allegedly prematurely deployed.It was further reported that the center of the stent allegedly elongated.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 stent delivery system was not returned for evaluation but a photo was provided demonstrating the deployed stent inside the vessel.A length measurement is not possible due to missing adequate scaling information.The stent appears irregularly deployed but a more detailed description is not possible due to poor resolution.Premature deployment cannot be identified on this image.Device compatible guidewire and introducer were used and there was pre- dilatation, but the system was used in the venous system which is off label.The investigation leads to confirmed result for stent deformation.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use states that "flush the stent delivery system with sterile saline using a small volume (e.G., 5 ¿ 10 cc) syringe.Attach the saline filled syringe to the two female luer ports, the first of which is located at the proximal end of the device and the second of which is found within the t-luer adapter.Continue flushing until saline drips from the distal tip of the catheter after flushing each luer port".The instructions for use further states "the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the transhepatic route, insert a 0.035¿ (0.89 mm) guidewire under fluoroscopic guidance through the biliary stricture and into the duodenum".Regarding general directions, the instructions for use states 'pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician'.Holding and handling of the system throughout deployment was found sufficiently described.The bard e luminexx biliary stent is indicated for the treatment of biliary strictures resulting from malignant neoplasms.H10: b5, d4 (expiry date: 05/2022), g3.H11: h6 (method, result, 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 in left subclavian vein, the stent allegedly prematurely deployed.It was further reported that the center of the stent allegedly elongated.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12726030
• Report Number: 9681442-2021-00572
• Device Sequence Number: 19967998
• Product Code: FGE
• UDI-Device Identifier: 04049519010434
• UDI-Public: (01)04049519010434
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: ZBM14040
• Device Catalogue Number: ZBM14040
• Device Lot Number: ANDS4703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 67 YR
• Patient Sex: Female