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

Catalog Number AASLE09100

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Misfire (2532); Material Deformation (2976)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

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 sample was returned for evaluation.The stents was found partially deployed.The slide block and the tether were not able to withstand the tension and were disconnected from the proximal sheath.Therefore a failure on the bond was determined the main factor, which led to the partial deployment of the stent.A kink was identified in the outer sheath; however, it is not know how and when this occurred and it is assumed as a consequence of the packaging during shipment.No deformation was identified.Based on the investigation of the provided information, the investigation is closed with confirmed results for failure of the bonding junction between proximal sheath, sliding block and tether; which led to the partial deployment of the stent.A definite root cause could not be identified.The device was used off-label.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: 'if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used.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.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." the covera¿ plus 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 and for the treatment of atherosclerotic lesions in iliac and femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.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.(expiry date: 10/2023).

• 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: 15136693
• MDR Text Key: 302434448
• Report Number: 9681442-2022-00225
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136245
• UDI-Public: (01)00801741136245
• 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
• Report Date: 07/14/2022

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: AASLE09100
• Device Lot Number: ANFX3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/30/2022
• 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
• Patient Sequence Number: 1