MAUDE Adverse Event Report: Angiomed GmbH & Co. Medizintechnik KG LifeStent 5F Vascular Stent

Catalog Number	5F060803CS
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2026
Type of Reportable Event	Serious 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50914949
• Report Number: 9681442-2026-00229
• Device Sequence Number: 5344839
• Product Code: NIP
• UDI-Device Identifier: 00801741120176
• UDI-Public: (01)00801741120176(17)290330(10)ANLQ4086
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5F060803CS
• Device Lot Number: ANLQ4086
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Male