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

Model Number	AVSM08060
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The return of the sample is pending.The company is still investigating the issue at this time.
Event or Problem Description
The report summarizes one malfunction.A review of the reported information indicates that model avsm08060, vascular covered stent, allegedly experienced malposition of the device.This information was "recieved" from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Event or Problem Description
The report summarizes one malfunction.A review of the reported information indicates that model avsm08060, vascular covered stent, allegedly experienced malposition of the device.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot no for the device was provided, therefore a lot history review was 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 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: 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: 9941539
• Report Number: 9681442-2020-00090
• Device Sequence Number: 11530700
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293
• 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): 06/19/2020

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: AVSM08060
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANDW3503
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1