MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number	5F070403CS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent stent placement procedure using lifestent 5f vascular stent.During the procedure the deployment wheel allegedly broke, thus stent was not deployed.
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 sample was not available for evaluation.One provided image only demonstrates the label section with a handwritten note.The reported issue could not be re produced without sample, which leads to inconclusive result.A manufacturing related issue could not be found.In this case only limited information is available such that indication for treatment, accessories used, and procedural details are not known.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.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction for use state: 'do not hold or touch the brown moving sheath during stent release (figure 9).Note: do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pta the instruction for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' regarding access/ accessories the instruction for use state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of appropriate length (table 2) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter (.)'.The instruction for use further state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.' g2, g3, h6 (device, component, 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 stent placement procedure using lifestent 5f vascular stent.During the procedure the deployment wheel allegedly broke, thus stent was not deployed.There was no reported patient injury.

• Brand Name: LIFESTENT 5F 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: 22629450
• Report Number: 9681442-2025-00221
• Device Sequence Number: 8155367
• Product Code: NIP
• UDI-Device Identifier: 00801741120312
• UDI-Public: (01)00801741120312(17)270827(10)ANJV3379
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• 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): 08/06/2025

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: 5F070403CS
• Device Lot Number: ANJV3379
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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