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

Model Number	AVFM08100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Device Overstimulation of Tissue (1991); Injury (2348)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Medical device - expiry date: 03/2021.
Event or Problem Description
It was reported through the results of a clinical trial, that during post-dilation of the vascular covered stent, spasm of the outflow vein occurred and was resolved with pta.The event was considered resolved and the patient was discharged the same day.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing related issue was considered; however, the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: a physical sample was not available for evaluation, and images have not been provided; the alleged spasm could not be re produced which led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.Labeling review:in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential issue.Regarding pre- and post- dilation, the ifu states: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated' and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vein.' the ifu further state 'potential complications may include, but are not limited to: thrombotic occlusion, restenosis requiring reintervention (.)'.Holding and handling of the system throughout deployment was found sufficiently described.H10: b7,d4 (expiry date: 03/2021),g4.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
It was reported through the results of a clinical trial, that during post-dilation of the vascular covered stent, spasm of the outflow vein occurred and was resolved with pta.The event was considered resolved and the patient was discharged the same day.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing related issue was considered; however, the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: a physical sample was not available for evaluation, and images have not been provided; the alleged spasm could not be re produced which led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential issue.Regarding pre- and post- dilation, the instructions for use states: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated' and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vein.' the instructions for use further state 'potential complications may include, but are not limited to: thrombotic occlusion, restenosis requiring reintervention.Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 03/2021),g3.H11: g1, h6 (patient).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
It was reported through the results of a clinical trial, that during post-dilation of the vascular covered stent, spasm of the outflow vein occurred and was resolved with pta.The event was considered resolved and the patient was discharged the same day.The current patient status was not provided.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 10605778
• Report Number: 9681442-2020-00208
• Device Sequence Number: 14188098
• Product Code: PFV
• UDI-Device Identifier: 00801741106538
• UDI-Public: (01)00801741106538
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVFM08100
• Device Catalogue Number: AVFM08100
• Device Lot Number: ANDQ1688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 06/21/2022
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 01/29/2021; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN AND CLOPIDOGREL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White