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

Catalog Number EX072003JL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number of the device was provided and lot history review will be performed.The device was not returned to the manufacturer for evaluation, therefore, the investigation of the reported event is inconclusive as no objective evidence was provided for review.The definitive root cause could not be established.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the lifestent solo vascular stent system products that are cleared in the us.The pro code for the lifestent solo vascular stent system products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ex072003jl vascular stent allegedly experienced failure to advance and positioning problem.This information was received from a single source.The malfunction involved a patient with no reported patient injury.The patient is a female and her weight and age were not provided.

• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10300301
• MDR Text Key: 199899010
• Report Number: 9681442-2020-00182
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112065
• UDI-Public: (01)00801741112065
• 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: 07/20/2020

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: EX072003JL
• Device Lot Number: ANDP0002
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1