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

Catalog Number 5F070601C

Device Problems Self-Activation or Keying (1557); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the events indicated that model 5f070601c vascular stent experienced self-activation and failure to advance.This report was received from one source.The device was not used in the patient.Patient 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8785806
• MDR Text Key: 150864317
• Report Number: 9681442-2019-00091
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120381
• UDI-Public: (01)00801741120381
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5F070601C
• Device Lot Number: ANCW1312
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1