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

Catalog Number EX062001JL

Device Problem 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 has not been returned for evaluation; therefore, the investigation is inconclusive for the positioning problem as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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 ex062001jl vascular stent allegedly experienced a positioning problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the device was provided and a lot history review was performed.The devices was not returned for evaluation and images have not been provided.Therefore, 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 ex062001jl vascular stent allegedly experienced a positioning problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender 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: 9940432
• MDR Text Key: 187388929
• Report Number: 9681442-2020-00082
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112034
• UDI-Public: (01)00801741112034
• 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: 06/18/2020

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: EX062001JL
• Device Lot Number: ANDT1789
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 06/18/2020
• Patient Sequence Number: 1