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

Model Number EX072003CL

Device Problems Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device and an image have been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ex072003cl vascular stent allegedly experienced a positioning issue and difficulty to remove.This information was received from one source.One patient was involved with no patient consequences.The age and weight of the female patient were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed positioning problem difficulty advancing, material deformation, and break.Based upon the available information, the definitive root cause 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 ex072003cl vascular stent allegedly experienced a positioning issue, difficulty to remove, material deformation, and a break.This information was received from one source.One patient was involved with no patient consequences.The age and weight of the female patient 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
• MDR Report Key: 9570381
• MDR Text Key: 174361418
• Report Number: 9681442-2020-00007
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402
• 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: 03/30/2020

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 Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANDU1853
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/01/2020
• Patient Sequence Number: 1