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

Catalog Number	AVSM09100
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure in the left cephalic vein at cephalic arch via the distal cephalic vein, the stent allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2025).H11: 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.
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 not available for evaluation; the stent remains implanted.X-ray images were provided.Based on these images no stent fracture and no defects of the structural integrity of the stent could not be verified.However, there are indications of an extravasation in the curve of the placed covered stent.Therefore, a hole or a puncture of the stent covering after placement is confirmed.Based on x-ray images provided, and additional stent was placed to treat the extravasation.It was alleged that a covered stent ruptured during post dilation using a balloon catheter.Based on x-ray images provided, the stent was placed in a curve, which may have caused stent struts to project into the lumen of the stent or the vessel, which may have perforated the balloon during post dilation.However, based on x-ray images provided, no stent fracture and no defects of the structural integrity of the stent could be verified.However, extravasation in the area of the curve could be confirmed, indicating that the covering of the stent must have been damaged in this area.Based on information available, a hole or a puncture of the stent covering after placement is confirmed, which caused extravasation in this area.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling of the device was reviewed.The instructions for use supplied with this product was found to address that complications and adverse events associated with the use of the covera¿ vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions.In particular covered stent specific events that could be associated with clinical complications include misplacement, migration, embolism, fracture, compression, kinking and insufficient covered stent expansion.Regarding precautions the instructions for use states: "post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.The covered stent cannot be post dilated beyond its labeled diameter." h10: d4 (expiration date: 02/2025), g3, h6 (device).H11: b5, h6 (patient, method, result, conclusion).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 left cephalic vein at cephalic arch via the distal cephalic vein, the stent allegedly ruptured.It was further reported that additional stent was placed inside the ruptured stent.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: 18984423
• Report Number: 9681442-2024-00062
• Device Sequence Number: 2969838
• Product Code: PFV
• UDI-Device Identifier: 00801741106361
• UDI-Public: (01)00801741106361
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 06/26/2024

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: AVSM09100
• Device Lot Number: ANHP0653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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 Sex: Unknown