SEE H10

Report

Report Number: 2015691-2017-03496
Event Type: Injury
Date Received: October 23, 2017
Date of Event: June 20, 2017
Report Date: September 29, 2017
Manufacturer: EDWARDS LIFESCIENCES
Product Code: LWR
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

Additional Manufacturer Narrative · 1

THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED FROM THE HEALTHCARE PROVIDER. HOWEVER, THERE IS CURRENTLY INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THE SURGEON NOTED THAT THE DEATH EVENT WAS NOT VALVE RELATED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative · 1

THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESES EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT IS LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH STRUCTURAL VALVE DETERIORATION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative · 1

THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESES EXPLANTS/REPLACEMENTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS AND/OR REGURGITATION. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. HOWEVER, THE STENOSIS AND REGURGITATION IN THIS CASE WERE LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

Description of Event or Problem · 1

IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT THIS PATIENT WITH A 21MM EDWARDS BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS DEVELOPED MODERATE AORTIC STENOSIS (MEAN GRADIENT 47MMHG/ PEAK GRADIENT 84 MMHG) AND MILD TO MODERATE REGURGITATION. THE DEVICE WAS NOT EXPLANTED. IT WAS LEARNT THAT THE PATIENT WAS HOSPITALIZED FOR ACUTE KIDNEY FAILURE. AFTER INITIATION OF DRAINAGE THERAPY, AN IMPROVEMENT WAS OBSERVED BUT AN ACUTE HEART DECOMPENSATION OCCURRED AND THE PATIENT EXPIRED. PER THE SURGEON, THE DEATH EVENT WAS NOT VALVE RELATED.

Description of Event or Problem · 1

IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT THIS PATIENT WITH A 21MM EDWARDS BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS DEVELOPED MODERATE AORTIC STENOSIS (MEAN GRADIENT 47MMHG/ PEAK GRADIENT 84 MMHG) AND MILD TO MODERATE REGURGITATION. THE DEVICE WAS NOT EXPLANTED. IT WAS LEARNT THAT THE PATIENT WAS HOSPITALIZED FOR ACUTE KIDNEY FAILURE. AFTER INITIATION OF DRAINAGE THERAPY, AN IMPROVEMENT WAS OBSERVED BUT AN ACUTE HEART DECOMPENSATION OCCURRED AND THE PATIENT EXPIRED. PER THE SURGEON, THE VALVE SHOWED SIGNS OF STRUCTURAL VALVE DETERIORATION (SVD). THE SURGEON STATED THAT THERE IS NO EVIDENCE THAT THE SVD WAS RELATED TO THE PATIENT'S DEATH, BUT THE LIKELIHOOD IS EXTREMELY HIGH.

Description of Event or Problem · 1

IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT THIS PATIENT WITH A 21MM EDWARDS BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS DEVELOPED MODERATE AORTIC STENOSIS (MEAN GRADIENT 47MMHG/ PEAK GRADIENT 84 MMHG) AND MILD TO MODERATE REGURGITATION. THE DEVICE WAS NOT EXPLANTED. IT WAS LEARNT THAT THE PATIENT WAS HOSPITALIZED FOR ACUTE KIDNEY FAILURE. AFTER INITIATION OF DRAINAGE THERAPY, AN IMPROVEMENT WAS OBSERVED BUT AN ACUTE HEART DECOMPENSATION OCCURRED AND THE PATIENT EXPIRED. PER THE (B)(6), THE EVENT OF DEATH WAS NOT AS RELATED TO THE STUDY DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT THIS PATIENT WITH A 21MM EDWARDS BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS SHOWED SIGNS OF STRUCTURAL VALVE DETERIORATION LEADING TO MODERATE AORTIC STENOSIS AND MILD TO MODERATE REGURGITATION. INDICATION FOR SURGERY WAS NATIVE AORTIC SEVERE STENOSIS WITH TRIVIAL REGURGITATION. THE THREE (3) MONTHS FOLLOW-UP ECHO SHOWED TRIVIAL REGURGITATION THAT WORSENED TO MILD REGURGITATION IN THE ONE (1) YEAR FOLLOW-UP ECHO. IT WAS LEARNED, THREE (3) YEARS AND ELEVEN (11) MONTHS LATER, THAT THE PATIENT WAS HOSPITALIZED FOR ACUTE KIDNEY FAILURE. AN ECHO SHOWED MODERATE BIOPROSTHETIC AORTIC STENOSIS (MEAN GRADIENT 47MMHG/ PEAK GRADIENT 84 MMHG) AND MILD TO MODERATE REGURGITATION. THE PATIENT WAS TREATED FOR THE ACUTE KIDNEY FAILURE. AFTER INITIATION OF DRAINAGE THERAPY, AN IMPROVEMENT WAS OBSERVED, BUT AFTER 19 DAYS IN THE HOSPITAL THERE WAS AN ACUTE HEART DECOMPENSATION AND THE PATIENT EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
748605	SEE H10	TISSUE, HEART-VALVE	LWR	EDWARDS LIFESCIENCES	8300ACB21

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Death\| H