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

Catalog Number	AVSM08060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records 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) are 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.Section a through f ¿ the information provided by bd represents all 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 study that approximately eight months, four weeks and a day later the subject underwent a re-intervention for access thrombosis and target lesion re-stenosis on the right arm.The target lesion was treated on the cephalic vein arch region with initial stenosis of 80% and final residual stenosis of 0%.It was further reported that the subject underwent re-intervention for target lesion re-stenosis.The target lesion was treated on the cephalic vein arch region with initial stenosis of 95% and final residual stenosis of 0%.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: 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: the physical sample was not returned for evaluation.No images were provided for review.Based on the information available, the investigation is closed with inconclusive result.No indications were found that the covera vascular covered stent used in the initial procedure was causally related to the reported issues or re-interventions.No specific device deficiencies or malfunctions were reported during or after the initial procedure.Potential factors that could have led or contributed to the event reported have been evaluated.Previously reported similar complaints were reviewed to find the root cause.Thrombosis or restenosis of a covered stent may be caused by various factors and may even occur inside non-defective stents that have been correctly placed.These may be related to the general condition of the patient, the vascular conditions of the patient, or to medication.Irregular placement or insufficient pre- and/or post dilatation may be contributing factors.In this case pre dilation as well as post dilation was performed; there was no report of any specific device deficiencies or malfunctions during or after the initial procedure.Based on the information available no indications were found that the covera vascular covered stent used in the initial procedure was causally related to the reported issues or re-interventions.However, the lot history records have been reviewed with special attention to the manufacturing and inspection of this products of this lot were found to have met the specification prior to shipment.Based on the information available a definite root cause for the event reported could not be determined.Labeling review: the relevant labeling for this product was reviewed.It was found that the instructions for use (ifu) sufficiently address the potential risk.Based on the ifu complications and adverse events associated with the use of the covera vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes access thrombosis and restenosis of the target vessel.Regarding pta 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.¿ g3, h6 (method).Section a through f ¿ the information provided by bd represents all 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 study that approximately eight months, four weeks and a day later the subject underwent a re-intervention for access thrombosis and target lesion re-stenosis on the right arm.The target lesion was treated on the cephalic vein arch region with initial stenosis of 80% and final residual stenosis of 0%.It was further reported that the subject underwent re-intervention for target lesion re-stenosis.The target lesion was treated on the cephalic vein arch region with initial stenosis of 95% and final residual stenosis of 0%.The current status of the patient was unknown.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22892569
• Report Number: 9681442-2025-00267
• Device Sequence Number: 15692782
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293(17)230305(10)ANFQ0971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Expiration Date: 03/05/2023
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANFQ0971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic
• Patient Race: White