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

Catalog Number UNK COVERA PLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2023

Event Type  Death  

Manufacturer Narrative

H10: date of death for the patients were not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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: (b)(6).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" that eight patients reportedly expired during perioperative evaluation of patients in hospital, and the primary cause of mortality is unknown.It was further reported that forty-two patients out of two hundred and eighty-four were reportedly expired during postoperative follow-up.Furthermore, of these forty-two patients, nine died due to aortic-related causes, and two died because of renal branch occlusion, followed by acute kidney injury and paraplegia.Reportedly, the remaining thirty-one patients were expired, and the primary cause of death is unknown.

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 eight patients reportedly expired during perioperative evaluation of patients in hospital, and the primary cause of mortality is unknown.It was further reported that forty-two patients out of two hundred and twenty-eight were reportedly expired during postoperative follow-up.Furthermore, of these forty-two patients, nine died due to aortic-related causes, and two died because of renal branch occlusion, followed by acute kidney injury and paraplegia.Reportedly, the remaining thirty-one patients were expired, and the primary cause of death is unknown.

Manufacturer Narrative

H10: date of death for the patients were not provided, date of death updated as on (b)(6) 1900 for the mdr submission requirement.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.This complaint record was opened, as the clinical article mentions that 8 of 284 patients died in the perioperative period, and 42 patients died during postoperative follow-up.However, there is no indication or presumption that the deaths may be related to a device deficiency or an insufficient performance of the placed covered stent.No device problem related to a death was documented.The covered stents were used off label.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." 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: h6 (method, result, conclusion).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.

• 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: 17555683
• MDR Text Key: 321227910
• Report Number: 9681442-2023-00296
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• 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
• Patient Outcome(s): Death