MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 12/ 80/135

Catalog Number ZVL12080

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.The investigation is inconclusive for migration or expulsion of device and malposition of device.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 zvl12080 vascular stent allegedly experienced migration or expulsion of device and malposition of device.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-ZVL 12/ 80/135
• 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: 10284018
• MDR Text Key: 199898357
• Report Number: 9681442-2020-00177
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146510
• UDI-Public: (01)00801741146510
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ZVL12080
• Device Lot Number: ANDX0534
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1