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

Catalog Number AASLE10100

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

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the superficial femoral vein, the stent allegedly failed to deploy.The procedure was completed using another 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 plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified.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 stent delivery system was returned for evaluation and the stent was found partially deployed; the slide block of this device, a force transmitting component was found no longer connected to the proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected from the proximal sheath, led to the partial deployment of the stent.The stents were used in the superficial and deep femoral artery to treat an aneurysm; which is off label use.System compatible accessories were used.Based on the investigation of the provided information, the investigation is confirmed for the adhesive joint (tether / proximal sheath / slide block) to withstand tension, which led to partial deployment of the covered stent.A definite 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.Regarding the indications for use the instructions for use state 'the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated.' (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: 15196727
• MDR Text Key: 298812935
• Report Number: 9681442-2022-00234
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136290
• UDI-Public: (01)00801741136290
• 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: Physician
• Type of Report: Initial
• Report Date: 07/29/2022

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: AASLE10100
• Device Lot Number: ANFX3587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/10/2022
• 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