SEE. H10.

Report

Report Number: 2015691-2020-14770
Event Type: Injury
Date Received: December 1, 2020
Date of Event: March 6, 2020
Report Date: November 9, 2020
Manufacturer: EDWARDS LIFESCIENCES
Product Code: LWR
PMA / PMN Number: SEE H10.
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

H10. ADDITIONAL MANUFACTURER NARRATIVE: ADDED INFORMATION TO D4, H4, H6. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

Additional Manufacturer Narrative · 0

H10. ADDITIONAL MANUFACTURER NARRATIVE: THE CAUSE OF THE EVENT WAS DUE TO PATIENT FACTORS AND PROGRESSION OF PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE DEVICE IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INSPIRIS RESILIA AORTIC VALVE, MODEL# 11500A, PMA# P150048. CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS AND PROGRESSION OF PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY LIKELY CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem · 1

EDWARDS RECEIVED INFORMATION A 21MM AORTIC VALVE IMPLANTED FIVE (5) YEARS, 11 MONTHS, WAS EXPLANTED DUE TO SEVERE SYMPTOMATIC AORTIC STENOSIS AND DEGENERATION SECONDARY TO CALCIFICATION. TRANSVERSE AORTOTOMY EXPOSED A HEAVILY CALCIFIED PROSTHETIC VALVE. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM NON-EDWARDS MECHANICAL VALVE. THE PATIENT ALSO UNDERWENT TRICUSPID VALVE REPAIR WITH A 32MM RING DURING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN CRITICAL, BUT STABLE, CONDITION. PATIENT HAD POST-OPERATIVE COMPLETE HEART BLOCK REQUIRING IMPLANT OF PERMANENT PACEMAKER. PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 34.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1394771	SEE. H10.	HEART-VALVE, NON-ALLOGRAFT TISSUE	LWR	EDWARDS LIFESCIENCES	SEE H10.

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization\| L\| R