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

Model Number 5F061501CS

Device Problems Difficult to Remove (1528); Misfire (2532); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for material deformation, partial deployment, device-device incompatibility and difficult to remove issue.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 5f061501cs vascular stent allegedly experienced partial deployment, material deformation, device-device incompatibility and difficult to remove.The information was received from a single source.One patient was involved with no reported patient injury.The patient age, weight and gender was 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: 10722675
• MDR Text Key: 213701290
• Report Number: 9681442-2020-00215
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120756
• UDI-Public: (01)00801741120756
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5F061501CS
• Device Catalogue Number: 5F061501CS
• Device Lot Number: ANCX4097
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1