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

Catalog Number UNK COVERA PLUS

Device Problems Fracture (1260); Off-Label Use (1494); Malposition of Device (2616)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not 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) are 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.H10: luca bertoglio, alessandro grandi, gian franco veraldi, raffaele pulli, michele antonello, stefano bonvini, et al., (2023).Mid-term results on a new self-expandable covered stent combined with branched stent-grafts: insights from a multicenter italian registry.Journal of vascular surgery, 77(6):1598-1606.E3.Doi: 10.1016/j.Jvs.2023.02.007.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported in an article in the journal of ¿vascular surgery¿ titled ¿mid-term results on a new self-expandable covered stent combined with branched stent-grafts: insights from a multicenter italian registry", that there were two occurrences of endoleak i/iii due to distal migration of the stent during deployment and one occurrence of stent rupture requiring relining of a new covera plus stent.There was no reported patient injury.

Manufacturer Narrative

H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of three for this event.H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not available for evaluation.No x-ray images were provided for review.Based on the information available, the reported device issues could not be confirmed and the investigation is closed with inconclusive result.The reported use of the devices during bevar procedures represents an off label use.Even though the off label use is considered being a potential cause respectively a contributing factor, a definite root cause could not be determined.Furthermore, it can be reasonably suggested that the users in these cases were aware of the off-label use of the products.Labeling review: current version of relevant labeling applicable for this product was reviewed.Based on the instructions for use the covera¿ plus vascular covered stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arteriovenous (av) fistula and at the venous anastomosis of an eptfe or other synthetic av graft.In addition the covera¿ plus vascular covered stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery.Therefore, the use of the device during bevar procedure represents an off label use.Precautions were found included in the instructions for use; e.G., "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established." other potential factors were found addressed as the instructions for use states: "using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire of appropriate length across the target lesion." in particular the instructions for use states: "do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement." potential complication and adverse events, which may occur were found to be addressed; e.G., covered stent collapse/compression, covered stent fracture, covered stent kinking, covered stent migration or covered stent misplacement.H10: luca bertoglio, alessandro grandi, gian franco veraldi, raffaele pulli, michele antonello, stefano bonvini, et al., (2023).Mid-term results on a new self-expandable covered stent combined with branched stent-grafts: insights from a multicenter italian registry.Journal of vascular surgery, 77(6):1598-1606.E3.Doi: 10.1016/j.Jvs.2023.02.007.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported in an article in the journal of ¿vascular surgery¿ titled ¿mid-term results on a new self-expandable covered stent combined with branched stent-grafts: insights from a multicenter italian registry", there were two occurrences of endoleak i/iii due to distal migration of the stent during deployment and one occurrence of stent rupture requiring relining of a new stent.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: 17567131
• MDR Text Key: 321372446
• Report Number: 9681442-2023-00297
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK COVERA PLUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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