MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Model Number	5F061203CS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported information, the physical sample was not returned so that a catheter related issue of the alleged stent fracture during deployment could not be investigated.One image was provided demonstrating one stent end of the deployed stent inside a vessel.Significant calcification was visible which led to an irregular appearance of the open cell design in one axial position.The resolution was poor so that the single stent struts were not visible.Stent elongation or foreshortening could not be identified; the stent body appeared with homogeneous contrast.A strut fracture could not be identified which led to an inconclusive evaluation result.Based on the information available and the evaluation of the returned sample a definite root cause for the reported issue could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the malfunction indicated that model 5f061203cs vascular stent allegedly fractured.This report was received from one source.He malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6) kgs.

• Brand Name: LIFESTENT 5F 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: 8783286
• Report Number: 9681442-2019-00085
• Device Sequence Number: 19336467
• Product Code: NIP
• UDI-Device Identifier: 00801741120190
• UDI-Public: (01)00801741120190
• 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): 07/11/2019

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: 5F061203CS
• Device Catalogue Number: 5F061203CS
• Device Lot Number: ANCW0638
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1