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

Model Number	AVFM10040
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100); Stenosis (2263)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing 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.The instruction for use (ifu) is adequate for the reported device/patient 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.
Event or Problem Description
It was reported through the results of a clinical trial, approximately 2-year post index procedure, partial thrombosis and 50-90% stenosis were identified.It was further reported that intervention was performed with successful result.
Event or Problem Description
It was reported through the results of a clinical trial, approximately 2-year post index procedure, partial thrombosis and occlusion was identified.It was further reported that intervention was performed with successful result.New information: it was reported through the results of a clinical trial, the partial experienced bumps on fistula and cephalic vein was occluded.It was further reported that surgical intervention was performed with successful result.
Additional Manufacturer Narrative
H10: manufacturing review: review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.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.Based on the information available a definite root cause for the event reported 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.' 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.H11: b5, h6 (patient: 1984 - occlusion).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 SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8941183
• Report Number: 9681442-2019-00144
• Device Sequence Number: 2584947
• Product Code: PFV
• UDI-Device Identifier: 00801741106583
• UDI-Public: (01)00801741106583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: AVFM10040
• Device Catalogue Number: AVFM10040
• Device Lot Number: ANAV0512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ASPIRIN; CLOPIDOGREL; CLOPIDOGREL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR