MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TA SHEATH UNKNOWN; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number TA SHEATH UNKNOWN

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/01/2014

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.The date of the events is unknown.According to the article all implants were completed between february 2014 and june 2017.For this reason, the first day of the range was used as the occurrence date.In this case, the exact valve model number is not available.Therefore, brand name of this report will reflect an unknown edwards sheath.The possible pma numbers associated with this article are: p130009 - edwards ascendra sheath and p140031- edwards certitude sheath.Per the instructions for use (ifu), cardiovascular injuries such as access site complications, perforation of the ventricle or myocardium, bleeding, and injury at the site of ventricular access may require repair and are known potential adverse events associated with the transapical thv procedure.Per the literature review, risk factors for apical laceration and bleeding include friable tissue, fatty apex, chronic steroid use, dilated lv with thinned walls, and hypertension during removal of the sheath.While patient characteristics are important, achieving good hemostatic control of the lv apex is one of the most critical steps in ensuring the success of the transapical procedure, particularly in the elderly with friable tissue.Additional literature review confirms there is a higher incidence of apical bleeding in female patients and patients over 80 years old.This information correlates with the review of complaint history, revealing that most apical during the insertion or removal of the sheath.The thv training manuals note that that removal of the sheath and attempted closure of the apical incision may be associated with blood loss.Rapid burst pacing can be used to lower the systemic blood pressure during sheath removal and apical closure.The thv training manuals also recommend the physician consider performing the procedure under full cpb support for certain patients, including those with cardiogenic shock (cardiac index < 2 l/min per square meter) despite volume challenge and inotropic support, profound lv, rv, or biventricular dysfunction, and notably friable apex.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.The cause of the event cannot be determined with the limited information provided.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Reference article: dritan useini, markus schlomicher, blerta beluli, hildegard christ, elias ewais.'''transapical transcatheter aortic valve implantation using the edwards sapien 3 valve'''.The journal of cardiovascular surgery 2021 december.

Event Description

As reported from our affiliates in germany, per article, ''transapical transcatheter aortic valve implantation using the edwards sapien 3 valve'', a study between february 2014 to june 2017 on 122 elderly patients with severe aortic stenosis underwent transapical transcatheter aortic valve replacement (tavr) with a sapien 3 valve.The following events were identified: major vascular complications were noted on 2 patients.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2023-10179 and 2015691-2023-10185.

• Brand Name: EDWARDS TA SHEATH UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16162688
• MDR Text Key: 307467969
• Report Number: 2015691-2023-10183
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TA SHEATH UNKNOWN
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• 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): Required Intervention