MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

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

Patient Problems Stroke/CVA (1770); Fistula (1862)

Event Type  Death  

Manufacturer Narrative

Device not returned.Per the instructions for use (ifu), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the thv procedure and the use of the edwards thv devices.According to the literature review, and as documented in a clinical technical summary , stroke is recognized in the literature as a wellknown complication in a small number of patients undergoing thv.Risk factors correlating with several patient comorbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intraprocedure embolic events.A transcranial doppler study during thv demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early postprocedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between thv and avr patients.After thv, there appears to be a more significant proportion of early strokes occurring < 24 h postprocedure, but thv patients with multiple comorbidities are probably at higher risk of both early and late strokes.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.Aortocardiac or intracardiac fistulas and shunts are relatively rare but can result from endocarditis, tissue trauma, or rupture of cardiac aneurysms.They have been reported as a rare complication following surgical or transcatheter aortic valve replacement.This type of defect in the cardiac tissues or aortic wall can result from trauma during percutaneous aortic valve implantation, additional invalve balloon dilation on a heavily calcified native aortic valve, or tissue erosion over time from calcified vegetations or the valve frame.Percutaneous or surgical closure of periprosthetic leaks may be required to close the communication.Per the instructions for use (ifu), stroke and fistulas are potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patients vascular tortuosity may have played caused or contributed to this event.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.

Event Description

Per published article, a sharp right turn: a case of aortic to right atrial fistula during transcatheter aortic valve replacement (tavr) left axillary access was obtained and used to place a 23mm sapien 3 ultra valve.No paravalvular leak was noted.After deployment of the valve, color doppler assessment revealed flow from the noncoronary sinus of valsalva to the right atrium (ra).Flow through the fistula was noted to be primarily during systole by continuous wave doppler, although some diastolic flow was also likely.The patient was observed for 2 hours after deployment of the valve.No other complications arose, and the patient was taken to the intensive care unit (icu) intubated for recovery.After weaning off sedation, the patient was noted to have right fascial droop and right hemiplegia.A grade 3 systolic murmur at the left lower sternal boarder, with no rubs, gallops, or thrills, was noted on physical examination at this time.A noncontrast computed tomography (ct) scan of the head revealed left middle cerebral artery stoke.On postprocedural day 1, the patient became hypotensive.Tee was negative for tamponade, and the patient was treated with vasoactive infusions.On postprocedural day 2, the patient developed anemia and thrombocytopenia.A computed tomography (ct) scan revealed a large, bilateral retroperitoneal hematoma extending from the level of the kidneys into the pelvis.The patient remained lethargic, without improvement of his neurologic symptoms.The patient was extubated in accordance with his wishes on postprocedural day 7 and died shortly after.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15443093
• MDR Text Key: 300116387
• Report Number: 2015691-2022-07946
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 91 YR
• Patient Sex: Male