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

Model Number 5F070403CS

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for material deformation.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f070403cs vascular stent allegedly experienced material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient was (b)(6) lbs.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10722678
• MDR Text Key: 213207939
• Report Number: 9681442-2020-00216
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120312
• UDI-Public: (01)00801741120312
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

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: 5F070403CS
• Device Catalogue Number: 5F070403CS
• Device Lot Number: ANDY2192
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1