MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM

Model Number	AVFM09060
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the event indicated that model avfm09060 vascular covered stent system allegedly experienced after deployment in the left femoral graft at the venous anastomosis via vein access, the delivery system reportedly required excessive force to retract from the distal end of the stent graft and caused the stent graft to bend inward.It was further reported that the stent graft underwent post-dilatation and was no longer deformed.This report was received from one source.This event involved one female patient, weighing (b)(6) lbs, age was not provided.There was no reported patient injury.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the event indicated that model avfm09060 vascular covered stent system allegedly experienced after deployment in the left femoral graft at the venous anastomosis via vein access, the delivery system reportedly required excessive force to retract from the distal end of the stent graft and caused the stent graft to bend inward.It was further reported that the stent graft underwent post-dilatation and was no longer deformed.This report was received from one source.This event involved one female patient, weighing 85lbs, age was not provided.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe AZ 76227 ; GM 76227
• MDR Report Key: 8798716
• Report Number: 9681442-2019-00111
• Device Sequence Number: 19634812
• Product Code: PFV
• UDI-Device Identifier: 00801741106552
• UDI-Public: (01)00801741106552
• 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): 10/17/2019

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: AVFM09060
• Device Catalogue Number: AVFM09060
• Device Lot Number: ANCX2684
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1