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

Model Number 5F061203CS

Device Problems Break (1069); Retraction Problem (1536); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10722733
• MDR Text Key: 213701485
• Report Number: 9681442-2020-00217
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120190
• UDI-Public: (01)00801741120190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5F061203CS
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANEP2360
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1