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

Catalog Number AVFLE09080

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 02/18/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the covera vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent are identified.Manufacturing review: the lot history record of this lot was 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: the sample was returned for evaluation.Based on the condition of this delivery system it is confirmed that the covered stent could not be deployed.A force transmitting catheter segment inside the handle was found to be broken due to increased deployment force.No indication for a manufacturing related cause was found during sample evaluation.A cd with dicom images document the reported use of the device during treatment of an aortic aneurysm, which represents an off label use.Based on the evaluation of the sample returned and the event information available the reported impossibility to deploy the stent was confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the current labeling for this product, the potential issue was found to be addressed.Based on the instructions for use delivery system specific events that could be associated with clinical complications include failure to deploy as well as high deployment forces.The reported use of the device during treatment of an abdominal aortic aneurysm represents an off label use of the device.Based on the instructions for use the covera vascular covered stent is indicated for the treatment of stenoses in the upper extremity venous outflow of patients dialyzing with an arterio-venous (av) access graft or fistula.Correct covered stent deployment was found to be properly described.(expiry date: 06/2021).

• Brand Name: COVERA 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12808052
• MDR Text Key: 280816206
• Report Number: 9681442-2021-00583
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106095
• UDI-Public: (01)00801741106095
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: AVFLE09080
• Device Lot Number: ANDT2812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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