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

Catalog Number AASLE08060

Device Problems Malposition of Device (2616); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, both the rollers allegedly rotated together.It was further reported that the stent allegedly jumped and didn't stay in the place.The procedure was completed using the same device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified.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.(expiration date: 02/2024).Device not returned.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.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 returned for evaluation, the stent remains implanted.No x-ray images were provided to verify the reported malpositioning of the stent.No x-ray images and no device sample was provided for evaluation.Based on information available the reported issue could not be reproduced and the investigation is closed with inconclusive result.A definite root cause could not be determined.The reported use of the device to treat a pseudoaneurysm represents an off label use.Labeling review: the relevant labeling for this product was reviewed.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, high deployment forces and inaccurate deployment.The functionality of the deployment mechanism is sufficiently described: "retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel (g) on the handle.The large deployment wheel is used for the initiation of deployment and a slower deployment rate whereas the small deployment wheel (h) may be used for faster deployment after initiation." the reported use of the device to treat an pseudoaneurysm represents an off label use.Based on the instructions for use supplied with this product, the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated.H10: (expiration date: 02/2024).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.H3 other text: device not returned.

Event Description

It was reported that during a stent graft placement procedure in brachial artery pseudoaneurysm, both the rollers allegedly rotated together.It was further reported that stent allegedly jumped and didn't stay in the place.The procedure was completed using the same device.There was no reported patient injury.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: 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: 16406890
• MDR Text Key: 310193229
• Report Number: 9681442-2023-00041
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136177
• UDI-Public: (01)00801741136177
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE08060
• Device Lot Number: ANGP3542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1