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

Model Number AVSM08060

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Material Deformation (2976)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

A voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or malpositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.  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.A kink was found on the system but the relation of the kink to the issue is not known, and a kink was not reported.It is considered the disconnection of the slide block led to the reported impossibility to deploy the stent which leads to confirmed results.A force transmitting adhesive joint of the deployment mechanism was found loose which made a successful deployment impossible.It was indicated that the device was flushed.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 correct deployment the instructions 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." based on the instructions for use material required for a procedure using the covera vascular covered stent are 0.035 inch guidewire of appropriate length, introducer sheath with appropriate inner diameter.Regarding preparation 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.With regards to instructions for use, the instructions for use states "examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed".Expiry date: 11/2023.

Event Description

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

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16215650
• MDR Text Key: 307817481
• Report Number: 9681442-2023-00004
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM08060
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANFY2512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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
• Removal/Correction Number: RES 91359
• Patient Sequence Number: 1