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

Model Number	5F070803CS
Medical Device Problem Codes	Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event 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 5f070803cs vascular stent system allegedly experienced material deformation and malposition of the device.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
The device for this malfunction has been returned to bd for evaluation.The corporate lot number for the returned device was updated to anbx1218.The investigation is inconclusive for material deformation and malposition of device.Based on the information provided, 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 5f070803cs vascular stent system allegedly experienced material deformation and malposition of the device.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.

• 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: 8814072
• Report Number: 9681442-2019-00134
• Device Sequence Number: 14099903
• Product Code: NIP
• UDI-Device Identifier: 00801741120336
• UDI-Public: (01)00801741120336
• 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): 10/09/2019

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: 5F070803CS
• Device Catalogue Number: 5F070803CS
• Device Lot Number: ANBX1218
• 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: 10/09/2019
• Patient Sequence Number: 1