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

Catalog Number	VIUS10060
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using the lifestar vascular stent.During the procedure, it came to notice that the radiopaque marker was not in the correct location on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not 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.D2b (nio; fge) 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: 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, no specific lot was provided, therefore, no dhr-review could be performed.Investigation summary: the stent delivery system was not returned for evaluation and photos were not provided which leads to inconclusive results.There was no indication for a manufacturing deficiency.In this case, only very limited information was provided and a clear description of the whole event is not provided.Based on the available limited information and as the sample was not available for evaluation, the investigation is closed with inconclusive results for component misassembly.A definite root cause of the reported incident can not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.About device description, the ifu states "a single radiopaque marker on the outer catheter (d) of the delivery system is attached approximately 6 mm proximal to the distal end of the delivery system.Prior to deployment, this radiopaque marker overlaps the distal markers on the stent".Regarding warnings, the ifu states "visually inspect the bard lifestar biliary stent system (or bard lifestar vascular stent system) to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".The ifu further states that "there are four radiopaque tantalum markers on each end of the stent and an additional radiopaque marker band on the outer catheter of the delivery system.In its compressed stage, the tantalum markers appear like a contiguous band at each end of the stent" d2b (nio; fge), e1, e3, g2, g3, h6 (device, method).Section a through f ¿ the information provided 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 stent placement procedure using the lifestar vascular stent.During the procedure, it came to notice that the radiopaque marker was not in the correct location on the catheter.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using the lifestar vascular stent.During the procedure, it came to notice that the radiopaque marker was not in the correct location on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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, no specific lot was provided, therefore, no dhr-review could be performed.Investigation summary: the stent delivery system was not returned for evaluation and photos were not provided which leads to inconclusive results.There was no indication for a manufacturing deficiency.In this case, only very limited information was provided, and a clear description of the whole event is not provided.Based on the available limited information and as the sample was not available for evaluation, the investigation is closed with inconclusive results for component misassembly.A definite root cause of the reported incident cannot be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.About device description, the ifu states "a single radiopaque marker on the outer catheter (d) of the delivery system is attached approximately 6 mm proximal to the distal end of the delivery system.Prior to deployment, this radiopaque marker overlaps the distal markers on the stent".Regarding warnings, the ifu states "visually inspect the bard lifestar biliary stent system (or bard lifestar vascular stent system) to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".The ifu further states that "there are four radiopaque tantalum markers on each end of the stent and an additional radiopaque marker band on the outer catheter of the delivery system.In its compressed stage, the tantalum markers appear like a contiguous band at each end of the stent" d2b (nio; fge), e1, e3, g2, g3, h6 (device, method).Section a through f ¿ the information provided 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.

• Brand Name: LIFESTAR VASCULAR 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: 22319000
• Report Number: 9681442-2025-00190
• Device Sequence Number: 21037551
• Product Code: NIO
• UDI-Device Identifier: 04049519005553
• UDI-Public: (01)04049519005553
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P080007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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 Catalogue Number: VIUS10060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 07/23/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/13/2025; 08/14/2025
• 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
• Patient Sex: Unknown