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

Catalog Number	AVSM07080
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Failure (1158); 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: 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 delivery system was returned for evaluation in activated condition; the covered stent was found partially deployed upon sample receipt.The slide block, a force transmitting component was no longer connected to the proximal sheath.The disconnection of the slide block is considered to have led to the reported impossibility to completely deploy the covered stent.It was reported that an 8fr introducer sheath was used for access, the tracking vessel was neither tortuous nor calcified and the device was flushed before use.Based on evaluation of the sample, the investigation is closed with confirmed results for bonding joint failure and partial deployment is considered a cascading event.A definite root cause for the reported event could not be established.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instructions for use states: "maintain a stationary hold on the white stability sheath during covered stent deployment.Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath relaxed and avoid tension." based on the instructions for use material required for a procedure using the cover a vascular covered stent are 0.035 inch guidewire of appropriate length , introducer sheath with appropriate inner diameter.Regarding preparation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." h10: d4 (expiry date: 09/2025) 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.
Event or Problem Description
It was reported that during a stent graft placement procedure in the left arm fistula graft, the device allegedly had did not deploy.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: 19792330
• Report Number: 9681442-2024-00195
• Device Sequence Number: 19869886
• Product Code: PFV
• UDI-Device Identifier: 00801741106255
• UDI-Public: (01)00801741106255
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 07/05/2024

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: AVSM07080
• Device Lot Number: ANHW3242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown