MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN 3 UNKNOWN

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

Patient Problem Cardiogenic Shock (2262)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-01112.The date and the event is unknown.According to the article, all implants were completed between 2017 and 2019.For this reason, the first day of the range was used as the occurrence date.In this case, the exact valve model number and serial number are not available.Patients undergoing the tavr procedure can be non-operative or high risk, have complex medical histories and multiple co-morbidities.Patient risk factors for hypotension include low ef, cad, chf, arteriosclerosis, hypovolemia, and anemia.Additionally, these patients are routinely administered multiple vasoactive drugs during the procedure and are intentionally made hypotensive, utilizing rapid ventricular pacing, to facilitate accurate valve deployment.As a result of these factors, intra-operative hypotension is not uncommon and is treated with standard therapies, including vasoactive drugs.It is also not uncommon to initiate brief chest compressions or cardiac massage to facilitate distribution of these vasoactive drugs.In some cases, these standard maneuvers are not adequate, and initiation of cardiopulmonary bypass (cpb), insertion of iabp, and/or conversion to open surgery is required.There are many potential causes for a patient's death following a cardiac surgical procedure, including post procedural complications unrelated to the device itself, and complications related to co-morbidities.Without additional information, it is not possible to determine if a relationship exists between the patient's death and the implanted valve.In this case, the cause of cardiogenic shock and subsequent death is unknown as the article did not provide detailed information.Other potential contributing factors are unknown as limited clinical information was provided in the article.There was no allegation or indication a device malfunction contributed to this adverse event.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 on a monthly basis, 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: joseph lamelas, m.D, ahmed alnajar, m.D.'early outcomes for surgical minimally invasive sapien 3 transcatheter mitral valve replacement'.The society of thoracic surgeons (2020).

Event Description

As written in an article, 'early outcomes for surgical minimally invasive sapien 3 transcatheter mitral valve replacement', a study between 2017-2019, 16 patients underwent a valve in valve procedure in the mitral position and the following was observed: 1 patient expired due to cardiogenic shock.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards lifesciences; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11281139
• MDR Text Key: 230344297
• Report Number: 2015691-2021-01114
• Device Sequence Number: 1
• Product Code: NPU
• 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,literatur
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN 3 UNKNOWN
• Device Catalogue Number: N/A
• Device Lot 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: 01/11/2021
• 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