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

Model Number	AVSM09080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one year and four days post index procedure, the subject developed seventy percent of stenosis.Standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The current patient status is not provided.
Additional Manufacturer Narrative
Manufacturing review: the lot history records of this lot were 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.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.The stent remains implanted.No x-ray images were provided for evaluation.No irregularities or complication occurred during initial stent placement; pre dilation of the lesion and post dilation of the stent was performed.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use 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 restenosis of the target vessel.Regarding pre and post dilation the instructions for use states: "pre-dilate the stenosis with a percutaneous transluminal angioplasty 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 vessel." holding and handling for regular deployment was found described.(expiry date: 05/2023).Device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that one year and four days post a vascular covered straight stent graft placement in the cephalic vein at cephalic vein arch via the left upper arm access, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to pulsatility and outflow stenosis.Standard percutaneous transluminal angioplasty procedure was performed to treat pulsatility and outflow stenosis.Treatment re-intervention was successful, no new access created, and the outcome was resolved.It was further reported that one year, seven months, and eight days post a vascular covered straight stent graft placement in the cephalic vein at cephalic vein arch via the left upper arm access, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to pulsatility.Standard percutaneous transluminal angioplasty procedure was performed to treat pulsatility.Treatment re-intervention was successful, no new access created, and the outcome was resolved.Reportedly, there have been no documented device deficiencies, and no adverse events were reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were 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.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.The stent remains implanted.No x-ray images were provided for evaluation.Therefore, the reported restenosis could not be verified.No irregularities or complication occurred during initial stent placement; pre dilation of the lesion and post dilation of the stent was performed.Based on the information available the investigation is closed with inconclusive 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 risk.Based on the instructions for use 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 restenosis of the target vessel.Regarding pre and post dilation the instructions for use states: "pre-dilate the stenosis with a percutaneous transluminal angioplasty 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 vessel." holding and handling for regular deployment was found described.H10: d4 (expiry date: 05/2023) h11: b5 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
• 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: 15956042
• Report Number: 9681442-2022-00360
• Device Sequence Number: 6562011
• Product Code: PFV
• UDI-Device Identifier: 00801741106354
• UDI-Public: (01)00801741106354
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/24/2024

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: AVSM09080
• Device Catalogue Number: AVSM09080
• Device Lot Number: ANFS2135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 12/10/2022
• Supplement Report FDA Received Date: 07/04/2024
• 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: 70 KG
• Patient Ethnicity: Hispanic