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

Model Number	EX062003CL
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.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.The catalog number identified in 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model ex062003cl vascular stent allegedly experienced material deformation.This information was received from one source.This event involved one patient with no patient consequences.The (b)(6) male patient was (b)(6).

• 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: 10272083
• Report Number: 9681442-2020-00157
• Device Sequence Number: 803576
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• 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
• Report Date (Section B): 07/14/2020

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: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANDN2410
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/14/2020
• Patient Sequence Number: 1