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

Catalog Number	VIUS14120
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 a patient underwent a placement of lifestar stent on the left side of undefined access site.Prior to the procedure, physician looked for the stents that were placed in month of (b)(6) 2025.One of the stents had migrated up to cava towards the heart, and the patient was sent to hospital, and the stent was snared out using the sheath.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: 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 physical sample was returned for evaluation.Images/ photo or video were not provided fore review.In this case poor procedural information is available but the stent was placed in the venous system which is off label, and which is considered a significant factor.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.The reported indication represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use (ifu) describes holding and handling of the system for regular deployment including accessories to be used and pta.Regarding stent sizing the ifu state: 'appropriate diameter sizing of the stent to the target lesion is required to reduce the possibility of stent migration.(.) use the following guidelines for proper stent diameter selection.For target lumens ranging from 5 mm to 9 mm, select a stent with an unconstrained diameter of 1 mm larger than the target lumen.For target lumens ranging from 9 mm to 13 mm, select a stent with an unconstrained diameter of 1 to 2 mm larger than the target lumen.' the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms.The ifu state: 'the safety and effectiveness of this device for use in the vascular system have not been established.' g2, g3, h6 (method, result, conclusion) 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.
Event or Problem Description
On (b)(6) 2025 a patient underwent a placement of lifestar stent on the left side of undefined access site.Prior to the procedure physician looked for the stents that were placed in month of july one of the stent had migrated up to cava towards the heart, and the patient was sent to hospital, and the stent was snared out using the sheath.

• Brand Name: LIFESTAR BILIARY STENT
• Common Device Name: VASCULAR 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23276232
• Report Number: 9681442-2025-00333
• Device Sequence Number: 15667172
• Product Code: FGE
• UDI-Device Identifier: 04049519005720
• UDI-Public: (01)04049519005720(17)280128(10)ANKN3056
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Catalogue Number: VIUS14120
• Device Lot Number: ANKN3056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown