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

Model Number 5F061203CS

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, therefore a lot history review was not performed.The sample was not returned and the investigation is inconclusive for stent foreshortening/ jumping.The definitive root cause could not be determined based upon available information.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f061203cs lifestent 5f vascular stent system allegedly experienced malposition of device and material deformation.This information was received from one source.This malfunction involved one patient with no consequences.The (b)(6) year old patient's 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 Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10722674
• MDR Text Key: 213701021
• Report Number: 9681442-2020-00214
• 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 a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5F061203CS
• Device Catalogue Number: 5F061203CS
• Device Lot Number: ANDV4504
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1