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

Catalog Number	AVSM09060
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provide 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
On (b)(6) 2025, a patient underwent a stent placement procedure using covera stent.It was reported that during procedure, the covera stent was not deployed.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the lot history records of the reported lot were reviewed with special attention to the manufacturing and inspection of this product.Based on this review the products of this lot were found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation.The covered stent was found partially deployed upon receipt, the outer sheath was retracted.The safety lock slider was found in the open position.The handle of the delivery system was opened to inspect the inner assembly; however, no mechanical defects were identified.An attempt to deploy the stent was performed by rotating the deployment wheel, and the stent was successfully deployed on the laboratory table without any issues.In this case no indication for a use of inadequate accessories or a difficult patient anatomy were reported.During sample evaluation, no defect or the stent deployment system and no indication for a manufacturing related cause could be identified.Based on evaluation of the delivery system returned partial deployment of the stent is confirmed.However, an indication for a device related defect could not be determined.Based on the information available and evaluation of the sample returned a definite root cause could not be identified.Labeling review: the labeling supplied with this product was reviewed.The potential risk associated with the reported issue is addressed in the instructions for use (ifu).Based on the instruction 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.Correct preparation and deployment of the covered stent was found described.In particular the instruction 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." according to the instruction for use of 0.035 inch guidewire of appropriate length and use of an introducer sheath with appropriate inner diameter are required and the lesion should be pre-dilated with a pta balloon catheter of appropriate length and diameter.D9, e1, g3, h3, h6 (method, result, conclusion).Section a through f ¿ the information provide 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
On (b)(6) 2025, a patient underwent a stent placement procedure using covera stent.It was reported that during procedure, the covera stent was not deployed.The procedure was completed by 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: 23741123
• Report Number: 9681442-2025-00396
• Device Sequence Number: 18667003
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347(17)270227(10)ANKP3812
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: AVSM09060
• Device Lot Number: ANKP3812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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