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

Model Number	5F070603CS
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 device has not been returned for evaluation; therefore, the investigation is inconclusive for material deformation 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f070603cs vascular stent system allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequence.The patient was female and the age and weight were not reported.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f070603cs vascular stent system allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequence.The patient was female and the age and weight were not reported.
Additional Manufacturer Narrative
H10: a lot history review was performed.The device was returned for evaluation.Images were provided and reviewed.The investigation is inconclusive for material deformation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11: g1, h6(method, results).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.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8813761
• Report Number: 9681442-2019-00133
• Device Sequence Number: 2562800
• Product Code: NIP
• UDI-Device Identifier: 00801741120329
• UDI-Public: (01)00801741120329
• 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): 10/22/2019

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: 5F070603CS
• Device Catalogue Number: 5F070603CS
• Device Lot Number: ANCT4349
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1