MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVM 10/ 60/80

Catalog Number ZVM10060

Device Problems Failure to Advance (2524); Positioning Problem (3009)

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 products that are cleared in the us.The pro code for the e-luminexx products is identified.As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation, therefore, the investigation is inconclusive for the reported advancement and positioning issues.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model zvm10060 vascular stent allegedly experienced failure to advance and positioning problem.This information was received from one source.The one reported malfunction involved one patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: E-LUMINEXX VASCULAR STENT - MT-6F-ZVM 10/ 60/80
• 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: 10760017
• MDR Text Key: 213886643
• Report Number: 9681442-2020-00240
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147142
• UDI-Public: (01)00801741147142
• 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: 10/29/2020

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: ZVM10060
• Device Lot Number: ANDV4376
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1