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

Catalog Number EX071501JL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number was provided, a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged material deformation and malposition issues.A root cause could not be determined.The device was labeled for single use.

Event Description

The report summarizes one malfunction.A review of reported information indicates that model ex071501jl, vascular stent, allegedly experienced material deformation and malposition of device.This information was recieved from a single source.This malfunction involved an (b)(6) year old male patient with no consequences.The patient's weight was not provided.

• Brand Name: LIFESTENT SOLO 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: 9570384
• MDR Text Key: 179114710
• Report Number: 9681442-2020-00006
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110290
• UDI-Public: (01)00801741110290
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EX071501JL
• Device Lot Number: ANCN0366
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1