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

Model Number	EX090603CD
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Fracture (1260); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation; however, photos and images were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2022).
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly would not come off of the catheter.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 returned to the manufacturer for evaluation.Based on the investigation of the returned delivery system it was confirmed that the user could only partially deploy the stent and that the stent was fractured as subsequent event.Inside the grip, the force transmitting post was broken which made a successful deployment with the wheel impossible.Also, the guidewire lumen was found broken twice, and the stent sheath was found fully retracted.The investigation is confirmed for break of a force transmitting component.An indication for a manufacturing related cause could not be identified.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction 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.' the lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree, 'the safety and effectiveness of this device for use in the vascular system have not been established.' h10: d4 (expiry date: 03/2022), g3.H11: b5, h6 (device, 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.H3 other text : see h10.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly failed to deploy.It was further reported that a portion of the stent segment fractured and remained in the patient and was stented against the vessel wall.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11587358
• Report Number: 9681442-2021-00183
• Device Sequence Number: 2955469
• Product Code: FGE
• UDI-Device Identifier: 04049519000503
• UDI-Public: (01)04049519000503
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/29/2021

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: EX090603CD
• Device Catalogue Number: EX090603CD
• Device Lot Number: ANEQ1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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
• Patient Age: 56 YR