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	Bacterial Infection (1735); Stenosis (2263); Restenosis (4576)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that six months and fifteen days post a vascular covered straight stent graft placement in the cephalic vein at cephalic vein arch via the right upper arm access, the subject had an adverse event of methicillin-resistant staphylococcus aureus gram-positive bacterial infection.It was further reported that one year, three months, and twenty-four days post a vascular covered straight stent graft placement, the subject had serious adverse event of kink in cephalic vein causing stenosis in the mid arm approximately twelve centimeters proximal to the stent.Surgical revision was performed to treat the kink in cephalic vein causing stenosis in the mid arm approximately twelve centimeters proximal to the stent.Treatment re-intervention was successful and no new access created.Reportedly, the outcome of the serious adverse event was resolved.It was also reported that one year, four months, and three days post a vascular covered straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to elevated venous pressures and pulsatility.Standard percutaneous transluminal angioplasty procedure was performed to treat elevated venous pressures and pulsatility.Treatment re-intervention was successful, no new access created, and the outcome was recovered.Furthermore, one year, seven months, and twenty-four days post a vascular covered straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to prolonged bleeding, pulsatility, and pseudoaneurysm.Standard percutaneous transluminal angioplasty procedure was performed to treat prolonged bleeding, pulsatility, and pseudoaneurysm.Treatment re-intervention was successful, no new access created, and the outcome was recovered.Reportedly, there have been no documented device deficiencies, and no secondary stage procedures were reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
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: 03/2024) 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 six months and fifteen days post a vascular covered straight stent graft placement in the cephalic vein at cephalic vein arch via the right upper arm access, the subject had an adverse event of methicillin-resistant staphylococcus aureus gram-positive bacterial infection.It was further reported that one year, three months, and twenty-four days post a vascular covered straight stent graft placement, the subject had serious adverse event of kink in cephalic vein causing stenosis in the mid arm approximately twelve centimeters proximal to the stent.Surgical revision was performed to treat the kink in cephalic vein causing stenosis in the mid arm approximately twelve centimeters proximal to the stent.Treatment re-intervention was successful and no new access created.Reportedly, the outcome of the serious adverse event was resolved.It was also reported that one year, four months, and three days post a vascular covered straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to elevated venous pressures and pulsatility.Standard percutaneous transluminal angioplasty procedure was performed to treat elevated venous pressures and pulsatility.Treatment re-intervention was successful, no new access created, and the outcome was recovered.Furthermore, one year, seven months, and twenty-four days post a vascular covered straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to prolonged bleeding, pulsatility, and pseudoaneurysm.Standard percutaneous transluminal angioplasty procedure was performed to treat prolonged bleeding, pulsatility, and pseudoaneurysm.Treatment re-intervention was successful, no new access created, and the outcome was recovered.Reportedly, there have been no documented device deficiencies, and no secondary stage procedures were reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr rpt# 9681442-2024-00180 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 9681442-2024-00089.H10: g3 h11: d4 (unique identifier (udi) #) 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.

• 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: 19757957
• Report Number: 9681442-2024-00180
• Device Sequence Number: 6607733
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293(17)240311(10)ANGQ1643
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Expiration Date: 03/11/2024
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANGQ1643
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White