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

Catalog Number AASLE07100

Device Problems Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in common device name and pma/510k.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.Investigation summary: the delivery system was returned for evaluation and the slide block which is a force transmitting component was no longer connected to the proximal sheath.The proximal sheath was equally broken.It is considered the disconnection of the slide block and the breakage of the proximal sheath led to the reported impossibility to deploy the stent which leads to confirmed results.Provided photos show a broken proximal sheath.A force transmitting adhesive joint of the deployment mechanism was found loose which made a successful deployment impossible.This may be a result of increased deployment forces during deployment.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definitive root cause could not be determined based upon the available information.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 the precautions prior to deployment, the instructions for use state: '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.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation and accessories, 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." and "0.035-inch (0.89 mm) guidewire of appropriate length introducer sheath with appropriate inner diameter and length." expiration date: 01/2023.

Event Description

It was reported that during a stent placement procedure in superficial femoral artery, the triaxial wheel was not working properly and got free which lead to no deployment.It was further reported that the deployment handle was forced to open the stent but was unsuccessful, and deployment could not be achieved.The procedure was completed using another 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: 16326615
• MDR Text Key: 309076921
• Report Number: 9681442-2023-00019
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136146
• UDI-Public: (01)00801741136146
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE07100
• Device Lot Number: ANFN3935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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
• Patient Age: 37 YR
• Patient Sex: Male