MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT -MT-6F-ZVL 14/80/135

Catalog Number ZVL14080

Device Problems Labelling, Instructions for Use or Training Problem (1318); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent - mt-6f-zvl 14/ 80/135 products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent - mt-6f-zvl 14/ 80/135 products are identified.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A root cause has not been determined.The devices was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model zvl14080 vascular stent allegedly experienced labelling, instructions for use or training problem and packaging problem.This report was received from a single source.This event did not involve patient with no patient contact.The patient is male and (b)(6) years old; however, the patients weight was not provided.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent - mt-6f-zvl 14/ 80/135 products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent - mt-6f-zvl 14/ 80/135 products are identified in d2 and g5.H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, photo was provided.The investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model zvl14080 vascular stent allegedly experienced labelling, instructions for use or training problem and packaging problem.This report was received from a single source.This event did not involve patient with no patient contact.The patient is male and 60 years old; however, the patients weight was not provided.

• Brand Name: E-LUMINEXX VASCULAR STENT -MT-6F-ZVL 14/80/135
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9955505
• MDR Text Key: 187521548
• Report Number: 9681442-2020-00097
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146596
• UDI-Public: (01)00801741146596
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ZVL14080
• Device Lot Number: ANDU1020
• Date Manufacturer Received: 06/24/2020
• Patient Sequence Number: 1