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

Catalog Number VIES10100

Device Problems Difficult to Remove (1528); Misfire (2532); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation as well as photo was provided, and reviewed.Therefore, the investigation is inconclusive for partial stent deployment, positioning problem and difficult to remove.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model vies10100 vascular stent allegedly experienced partial deployment, positioning problem, and difficult to remove.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The female patient is (b)(6) years old and weighs (b)(6).

• Brand Name: LIFESTAR 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: 10716309
• MDR Text Key: 212468815
• Report Number: 9681442-2020-00209
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519006116
• UDI-Public: (01)04049519006116
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VIES10100
• Device Lot Number: ANBZ1010
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1