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

Catalog Number	VIUS09060
Medical Device Problem Codes	Misfire (2532); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using a lifestar vascular stent.During the procedure, stent did not deploy fully, only partially deployed.There was no reported patient injury.
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: 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 stent delivery system was not returned for evaluation and a provided photo shows the stent to be partially deployed which leads to confirmed results.In this case, it was reported that a 7f introducer was used with a 0.035" guidewire for access, the tracking vessel was neither tortuous nor calcified and the lesion was pre-dilated.The intended use of the lifestar vascular stent in an av graft of the upper arm indicates an off-label use.Based on provided photo, the investigation is closed with confirmed results for partial deployment.A definite root cause of the reported incident can not be identified.The intended use of the device in the upper arm indicates an off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.With regards to preparations, the ifu states "flush the stent delivery system with sterile saline using a small volume (e.G., 5 ¿ 10 cc) syringe.(.).Continue flushing until saline drips from the distal tip of the flexible catheter tip after flushing each luer port".Regarding warnings, the ifu states "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".Regarding accessories, the ifu states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath and a 0.035¿ (0.89 mm) guidewire.The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the ifu states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The ifu states that "the bard lifestar vascular stent system is indicated for the treatment of illiac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length with a reference vessel diameter of 5 to 9 mm", and "the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms." d2b (nio; fge), d4 (medical device expiration date, unique identifier (udi) #), g3, h6 (device, component, 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 stent placement procedure using a lifestar vascular stent.During the procedure, the stent did not deploy fully, only partially deployed.There was no reported patient injury.

• 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: 23422339
• Report Number: 9681442-2025-00355
• Device Sequence Number: 20893559
• Product Code: NIO
• UDI-Device Identifier: 04049519005485
• UDI-Public: (01)04049519005485(17)270702(10)ANJU0288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: VIUS09060
• Device Lot Number: ANJU0288
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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