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

Catalog Number	5F070601CS
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 is currently being performed.The return of the sample is pending.However, images 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure in extremely diseased artery using the lifestent 5f vascular stent.During the procedure, the life stent allegedly fractured in half.
Additional Manufacturer Narrative
H11: this supplemental mdr is being submitted to report that mfr rpt# 9681442-2025-00214 was a duplicate record and was opened in error.The event details are being captured under complaint file #: (b)(4) and was reported to the fda under mfr rpt# 9681442-2025-00197.G3: 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 in extremely diseased artery using the lifestent 5f vascular stent.During the procedure, the life stent allegedly fractured in half.

• 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: 22504993
• Report Number: 9681442-2025-00214
• Device Sequence Number: 9246475
• Product Code: NIP
• UDI-Device Identifier: 00801741120251
• UDI-Public: (01)00801741120251(17)271001(10)ANJX0213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 5F070601CS
• Device Lot Number: ANJX0213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White