MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT BILIARY STENT

Model Number	EX100801CD
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 10/2022).
Event or Problem Description
It was reported that during a stent placement, the device allegedly had stent elongation.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 for evaluation and images were not provided.The alleged issue cannot be re produced which leads to inconclusive evaluation result.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout the procedure.In particular the instructions for use state: 'to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Note: do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.', and 'to ensure correctly deployed stent length, fluoroscopically monitor the distal and proximal stent marker position relative to the obstruction throughout the deployment process.' in regards to deployment difficulty the instructions for use state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.' h10: d4 (expiry date: 10/2022), g3.H11: h6 (method).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, the device allegedly had stent elongation.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11831639
• Report Number: 9681442-2021-00316
• Device Sequence Number: 4367109
• Product Code: FGE
• UDI-Device Identifier: 04049519000619
• UDI-Public: (01)04049519000619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053404
• 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): 10/21/2021

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: EX100801CD
• Device Catalogue Number: EX100801CD
• Device Lot Number: ANEX2051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 10/23/2021
• 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