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

Catalog Number	AVFM08080
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
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: 09/2025).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 that during a stent graft placement procedure in the proximal basilic vein via left femoral artery, when attempted to deploy the stent allegedly would only deploy halfway.It was further reported that the partially deployed stent was removed and re-cannulated left femoral artery graft on the venous aspect in order to remove the curve of the graft.Reportedly, the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing related root cause was considered; therefore, the lot history records 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.Investigation summary: neither sample nor image provided which leads to inconclusive result.A 8f introducer with 0.035" guidewire were used for access, and the user did not experience difficulty tracking the system to the lesion site.The system was accessed through a loop graft.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system was found described, in particular the instructions for use state: 'during covered stent release do not hold the 30 cm long distal catheter assembly segment as it must be free to move and slide into the white stability sheath.' the instructions for use further state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed.' under required material the instructions for use state 0.035-inch guidewire and introducer sheath with appropriate inner diameter.The packaging pictograms indicate the use of a 8f introducer.The instructions for use further state: 'the device has not been tested for tracking and deployment around an av loop graft.' expiration date: (b)(6) 2025.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 that during a stent graft placement procedure in the proximal basilic vein via left femoral artery, when attempted to deploy the stent allegedly would only deploy halfway.It was further reported that the partially deployed stent was removed and re-cannulated left femoral artery graft on the venous aspect in order to remove the curve of the graft.Reportedly, the procedure was completed using another device.There was no reported patient injury.

• 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: 19612775
• Report Number: 9681442-2024-00164
• Device Sequence Number: 12503356
• Product Code: PFV
• UDI-Device Identifier: 00801741106521
• UDI-Public: (01)00801741106521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AVFM08080
• Device Lot Number: ANHW3870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 52 KG