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

Catalog Number AASLE06080

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 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 12/2022).

Event Description

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

Manufacturer Narrative

H10: the catalog number identified in section d4 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 510k number for the covera plus vascular covered stent products is identified in d2 and g4.H10: 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: delivery system of a covered stent was returned for evaluation.Based on the evaluation of the sample it is confirmed that the user could not deploy the covered stent.Inside the grip a force transmitting adhesive joint was found loose which made a successful deployment impossible.No indication was found that a manufacturing related issue caused or contributed to the reported issue.Based on the information available the investigation is closed with confirmed result for adhesive joint failure leading to deployment failure.A definite root cause for the reported event could not be determined.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." 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 reported use of the device during an endovascular aneurysm repair represents an off label use.Based on the instructions for use supplied with this product the '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.' h10: d4 (expiry date: 12/2022), g3, h6 (device).H11: h6 (method, result).

Event Description

It was reported that during a stent placement procedure, the stent allegedly failed to deploy.It was further reported that the wire inside the stent was allegedly broken.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12033058
• MDR Text Key: 258355756
• Report Number: 9681442-2021-00372
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 12/02/2021

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: AASLE06080
• Device Lot Number: ANEZ0859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/06/2021
• 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
• Patient Outcome(s): Other