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	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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) 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.H10: d4 (expiration date: 03/2023).H11: 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 trial that two months and twenty-six days post vascular covered straight stent placement in the cephalic vein at anastomotic via the right upper arm access, the subject developed an access circuit thrombosis which required additional arteriovenous access circuit re-intervention.It was further reported that four months and nine days post vascular covered straight stent placement in the cephalic vein at cephalic vein arch via the right upper arm access, the subject developed an access circuit thrombosis and target lesion restenosis which required additional arteriovenous access circuit re-intervention.It was also reported that standard percutaneous transluminal angioplasty balloon catheter procedure and thrombectomy were performed to treat the access circuit thrombosis and access circuit stenosis.Furthermore, the treatment re-intervention was successful, new access was not created, and the subject recovered.Reportedly, the subject expired, and the primary cause of death was cardiac arrest.Apparently, there have been no documented device deficiencies, and no adverse events were reported, and the relationship of the death was not related with the device, procedure and arteriovenous access circuit.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 sample was not returned for evaluation.No x-ray images were provided for evaluation.There was no alleged relation of the device to the reported access circuit thrombosis and no reported device deficiency.No indication for irregular stent placement was reported.Pre and post dilation was performed.Based on the information available the investigation is closed with inconclusive result.There was no reported device deficiency and no relation of the reported access circuit thrombosis alleged by the customer; a root cause for the adverse event could not be determined.Labeling review: relevant labeling applicable for this product was reviewed; it was found that the instruction for use sufficiently address the potential risk associated with the use of the covera vascular covered stent.Based on the instruction for use complications and adverse events may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes obstruction of flow and restenosis of the target vessel.H10: d4 (expiration date: 03/2023), g3.H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that two months and twenty-six days post vascular covered straight stent placement in the cephalic vein at anastomotic via the right upper arm access, the subject developed an access circuit thrombosis which required additional arteriovenous access circuit re-intervention.It was further reported that four months and nine days post vascular covered straight stent placement in the cephalic vein at cephalic vein arch via the right upper arm access, the subject developed an access circuit thrombosis and target lesion restenosis which required additional arteriovenous access circuit re-intervention.It was also reported that standard percutaneous transluminal angioplasty balloon catheter procedure and thrombectomy were performed to treat the access circuit thrombosis and access circuit stenosis.Furthermore, the treatment re-intervention was successful, new access was not created, and the subject recovered.Reportedly, the subject expired, and the primary cause of death was cardiac arrest.Apparently, there have been no documented device deficiencies, and no adverse events were reported, and the relationship of the death was not related with the device, procedure and arteriovenous access circuit.The current status of the patient is 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: 18371491
• Report Number: 9681442-2023-00405
• Device Sequence Number: 7722620
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293
• 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): 01/18/2024

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 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): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White