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

Model Number	AVSL09040
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/27/2017
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.Expiry date (02/2020).
Event or Problem Description
It was reported through the results of a clinical trial that approximately 9 months post index procedure, 60% stenosis was identified in the target lesion.It was further reported that standard pta was successfully performed for re-intervention due to the dysfunction in pulsatility.The current patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history record of this lot was 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 stenosis 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.' 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: 02/2020).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 approximately nine months post index procedure, 60% stenosis was identified in the target lesion.It was further reported that standard pta was successfully performed for re-intervention due to the dysfunction in pulsatility.The current patient status is unknown.

• 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: 9856134
• Report Number: 9681442-2020-00066
• Device Sequence Number: 3153410
• Product Code: PFV
• UDI-Device Identifier: 00801741106781
• UDI-Public: (01)00801741106781
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2021

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: AVSL09040
• Device Catalogue Number: AVSL09040
• Device Lot Number: ANAT1928
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 09/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 48