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

Model Number	AVSM09080
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
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 not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for evaluation, however, two images were provided.Therefore, the company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported malfunction indicated that model avsm09080 vascular covered stent allegedly failed to expand.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a (b)(6) year old female weighing (b)(6) lbs.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for evaluation, however, two images were provided.Based on the available information the investigation confirmed the alleged malfunction, however a definite root cause of the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported malfunction indicated that model avsm09080 vascular covered stent allegedly failed to expand.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a 50 year old female weighing 165 lbs.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9583526
• Report Number: 9681442-2020-00016
• Device Sequence Number: 10877457
• Product Code: PFV
• UDI-Device Identifier: 00801741106354
• UDI-Public: (01)00801741106354
• 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): 07/07/2020

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
• Operator of Device: No Information
• Device Model Number: AVSM09080
• Device Catalogue Number: AVSM09080
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1