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

Model Number	EX072003CL
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9570381
• Report Number: 9681442-2020-00007
• Device Sequence Number: 18942043
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANDU1853
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1