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

Model Number	5F061203CS
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation; however a photo was provided for review.Therefore, the investigation is confirmed for the catheter break.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 5f050803cs vascular stent allegedly break, retraction problem, material deformation and malposition problem.The information was received from a single source.The malfunction involved a patient with no known impact to the patient.The patients' age, weight and gender were not provided.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10722733
• Report Number: 9681442-2020-00217
• Device Sequence Number: 14268225
• Product Code: NIP
• UDI-Device Identifier: 00801741120190
• UDI-Public: (01)00801741120190
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: No Information
• Device Model Number: 5F061203CS
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANEP2360
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1