MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVM 10/ 80/80

Catalog Number ZVM10080

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code for the e-luminexx vascular stent products is identified.As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation is confirmed for positioning failure, detachment and material bent.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model zvm10080 vascular stent allegedly experienced positioning failure, detachment of device or device component and material twisted / bent.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.

• Brand Name: E-LUMINEXX VASCULAR STENT - MT-6F-ZVM 10/ 80/80
• 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: 11197644
• MDR Text Key: 227799416
• Report Number: 9681442-2021-80003
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147159
• UDI-Public: (01)00801741147159
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ZVM10080
• Device Lot Number: ANBV3051
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1