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

Model Number	AVSM07100
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
The lot number for the malfunction was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection.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 malfunction.A review of the reported information indicated that model avsm07100 vascular covered stent experienced failure to expand.This information was received from one source.The event involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection; the evaluation confirmed material deformation and failure to expand.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: b5; g4.H11: h6 (method, results, conclusion).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 avsm07100 vascular covered stent experienced failure to expand and material deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.

• 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: 9583847
• Report Number: 9681442-2020-00017
• Device Sequence Number: 374809
• Product Code: PFV
• UDI-Device Identifier: 00801741106262
• UDI-Public: (01)00801741106262
• 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): 04/02/2020

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: AVSM07100
• Device Catalogue Number: AVSM07100
• Device Lot Number: ANDV0185
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1