MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number	FEM10040
Medical Device Problem Codes	Difficult to Remove (1528); Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The lot number was provided and device history review performed.It was observed that the stent graft was partially deployed and one strut perforated the tip.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 fem10040 endovascular stent graft allegedly experienced a material perforation and a misfire.This information was received from a single source.The alleged a material perforation and misfire involved a patient with no known impact to the patient.The patient is a (b)(6) -year-old male; weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem10040 endovascular stent graft allegedly experienced a material perforation, difficulty to remove, and a misfire.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient is a 39-year-old male; weight was not provided.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The investigation is confirmed for material perforation, misfire, and difficulty to remove.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8805694
• Report Number: 9681442-2019-00118
• Device Sequence Number: 10844606
• Product Code: PFV
• UDI-Device Identifier: 04049519008585
• UDI-Public: (01)04049519008585
• 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): 10/18/2019

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: FEM10040
• Device Catalogue Number: FEM10040
• Device Lot Number: ANCX2558
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1