EDWARDS SAPIEN 3 ULTRA, 26MM
Report
- Report Number
- 2015691-2020-12561
- Event Type
- Injury
- Date Received
- July 17, 2020
- Date of Event
- June 16, 2020
- Report Date
- June 23, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION WAS RECEIVED. SECTION B7 WAS UPDATED. AT TIME OF IMPLANT TRACE PVL NOTED ON ECHO. DISCHARGE TTE SHOWED MILD PVL, EF (B)(4) , VMAX 2.5M/S, MEAN GRADIENT OF 13MMHG, AND EOA 1.2 CM2. ON POST-OPERATIVE DAY (POD) 1 THE PATIENT EXPERIENCED PERSISTENT POST-PROCEDURAL ANEMIA REQUIRING TREATMENT WITH IRON MEDICATION. AS PER PI CONSULT NOTES, ANEMIA WAS CONSIDERED STABLE AT 1 MONTH FOLLOW UP. THE PI ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE AND CAUSALLY RELATED TO THE IMPLANT PROCEDURE. THE EVENT OF ANEMIA WAS CONSIDERED ONGOING AT THE TIME OF THIS REPORT. ON POD 30, DURING THE 30 DAY FOLLOW-UP VISIT, A CONTROL TTE SHOWED MILD-MODERATE PVL, EF (B)(4) , VMAX 2.5 M/S, MEAN GRADIENT 13MMHG, AND EOA 1.6CM2. APPROXIMATELY 1 YEAR POST TAVR, A CONTROL TTE SHOWED MODERATE PVL, EF (B)(4) , VMAX 3.0 M/S, MEAN GRADIENT 19 MMHG, AND EOA 1.5CM2. IN THE FOLLOWING 6 WEEKS, THE PATIENT RECEIVED 6 BLOOD TRANSFUSIONS. A VALVE-IN-VALVE INTERVENTION BY TAVR HAS BEEN PLANNED. THERE WAS NO CLEAR EXPLANATION FOR PVL PROGRESSIVE WORSENING. IT LOOKS LIKE THE POST PROCEDURE PVL GRADING (TRACE PVL) MAY HAVE UNDERESTIMATED ITS SEVERITY. THE TTE IMAGES FROM 30 DAY FOLLOW-UP AND 1 YEAR FOLLOW-UP ARE QUITE SIMILAR, AND THE QUALITY OF THEM MADE IT DIFFICULT TO GRADE THE AORTIC PVL AS MILD-TO-MODERATE OR MODERATE. IN LIGHT OF THOSE FINDINGS, AND TAKING INTO ACCOUNT THAT THE PATIENT EXHIBITED SIGNS OF HEMOLYTIC ANEMIA, A TEE WAS PERFORMED. IN THIS EXAM, ENABLING BETTER IMAGE ACQUISITION, IT WAS CONFIRMED THAT THE GRADE OF PVL WAS MODERATE.
ADDITIONAL INFORMATION WAS RECEIVED. THE SAPIEN 3 ULTRA VALVE WAS NOT DEGENERATED. MILD-MODERATE PARAVALVULAR LEAK WAS PRESENT IMMEDIATELY POST-IMPLANTATION, AND THE INITIAL DECISION WAS TO NOT PERFORM BALLOON POST-DILATATION. THE PATIENT DEVELOPED A SEVERE HEMOLYSIS (REQUIRING UP TO 7 RED BLOOD CELL PACKS TRANSFUSION PER MONTH), WITHOUT ANY ETIOLOGY THAN THE PVL. APPROXIMATELY 1 YEAR AND 2 MONTHS POST TAVR PROCEDURE, A SAPIEN 3 VALVE WAS IMPLANTED WITHIN THE FIRST VALVE AND THE PVL WAS REDUCED TO TRACE. THE PATIENT WAS DOING WELL AND WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
UDI NUMBER: (B)(4) PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. HEMOLYSIS IS THE DESTRUCTION OF RED BLOOD CELLS. THERE ARE MULTIPLE EXTRINSIC AND INTRINSIC FACTORS INCLUDING USE OF EXTRACORPOREAL CIRCULATION, TRANSFUSION, INFECTION, TUMORS, AUTOIMMUNE DISORDERS, MEDICATION SIDE EFFECTS, A METABOLIC ABNORMALITY, AND RED BLOOD CELL MEMBRANE INSTABILITY. NORMAL RED BLOOD CELLS (ERYTHROCYTES) HAVE A LIFESPAN OF ABOUT 120 DAYS. AFTER THEY DIE THEY BREAK DOWN AND ARE REMOVED FROM THE CIRCULATION BY THE SPLEEN. IN SOME MEDICAL CONDITIONS, OR AS A RESULT OF TAKING CERTAIN MEDICATIONS, THIS BREAKDOWN OF RED BLOOD CELLS IS INCREASED. RED CELLS MAY BREAK DOWN DUE TO MECHANICAL DAMAGE, SUCH AS FROM ARTIFICIAL HEART VALVES OR HEART-LUNG BYPASS; OR THEY MAY BE DESTROYED DUE TO DEFECTS IN THE CELLS THEMSELVES. MEDICATIONS THAT HAVE BEEN ASSOCIATED WITH HEMOLYSIS INCLUDE ACETAMINOPHEN, PENICILLIN, AND OTHER PAIN MEDICATIONS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. IN THIS CASE, THE CAUSE FOR THE WORSENING PVL COULD NOT BE CONFIRMED. HOWEVER, PATIENT FACTORS LIKELY CONTRIBUTED TO THE PVL AND SUBSEQUENT HEMOLYSIS. 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.
AS REPORTED BY OUR AFFILIATES IN (B)(6), APPROXIMATELY 1 YEAR POST IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO WORSENING OF ANEMIA. TTE DEMONSTRATED AN INCREASE IN PARAVALVULAR REGURGITATION (PVL) FROM MILD TO MODERATE. THE PVL WAS THOUGHT TO HAVE CONTRIBUTED TO THE PATIENT¿S ANEMIA THROUGH A MECHANISM OF HEMOLYSIS. ADDITIONALLY, A DROP IN HEMOGLOBIN AND HAPTOGLOBIN WAS FOUND DURING THE 1 YEAR FOLLOW UP, CORROBORATING HEMOLYSIS. A PROCEDURE TO CLOSE THE PVL IS BEING CONSIDERED BY THE CLINICAL TEAM DUE TO THE OBSERVED HEMOLYSIS AND RESULTING WORSENING OF ANEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752555 | EDWARDS SAPIEN 3 ULTRA, 26MM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750TFX26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |