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

Catalog Number EX071001JL

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model ex071001jl, vascular stent, allegedly experienced a positioning issue.This information was received from one source.This malfunction involved a female patient with no consequences.The patients age and weight were 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: 9187830
• MDR Text Key: 169242838
• Report Number: 9681442-2019-00168
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110276
• UDI-Public: (01)00801741110276
• 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: 10/14/2019

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 Catalogue Number: EX071001JL
• Device Lot Number: ANCQ0583
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/14/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1