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

Catalog Number EX071701JL

Device Problems Material Deformation (2976); 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 indicated that model ex071701jl lifestent solo vascular stent system allegedly experienced material deformation and positioning failure.This information was received from one source.The material deformation and positioning issue involved one patient with no patient consequence.The patient was (b)(6) years old and weight was not reported.The reported patient was male.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8785816
• MDR Text Key: 150864152
• Report Number: 9681442-2019-00092
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110306
• UDI-Public: (01)00801741110306
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EX071701JL
• Device Lot Number: ANBT2919
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/12/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1