ON-X AORTIC HEART VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2016-00074
- Event Type
- Injury
- Date Received
- November 21, 2016
- Report Date
- February 3, 2017
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
ATTEMPTS TO OBTAIN ADDITIONAL CLARIFYING INFORMATION FROM DR. DONG HYUN YANG (PUBLICATION CONTACT AUTHOR) WERE MADE WITHOUT SUCCESS. THE FOLLOWING WAS ASKED VIA EMAIL ON 11/17/2016: SPECIFIC PRODUCT CODES, SERIAL NUMBER OF PRODUCTS REFERENCED, SPECIFIC EVENTS, DATES OF IMPLANT AND INTERVENTION, AND CURRENT PATIENT STATUS. AN EMAIL AND LETTER WERE SENT ON 11/21/2016 ADDRESSING THE FOLLOWING ADDITIONAL QUESTIONS: ¿CAN THEY PROVIDE THE PATIENT INFORMATION ABOUT THE ON-X PATIENT, AGE, LENGTH OF IMPLANT, OTHER DEMOGRAPHIC AND COMORBIDITY INFORMATION AND THE VARIABLES FROM THE TABLES FOR THAT PATIENT? WAS THE ON-X VALVE EXPLANTED? ANY PATHOLOGY PERFORMED? IF NOT, HOW WAS THE PATIENT TREATED? I ALSO ASKED MARKETING FOR A LISTING OF QUESTIONS THEY MAY HAVE.....COULD YOU PROVIDE DATA, INCLUDING ANY IMAGES, THAT ARE SPECIFIC TO THE ON-X VALVE RELATED TO PANNUS TO HELP US RULE OUT THINGS LIKE CANTERED OR MALPOSITIONED IMPLANT? IS POSSIBLE TO MISCONSTRUE SUB-VALVULAR PLEDGET ENCROACHMENT WITH PANNUS? DID THE SINGLE ON-X VALVE WITH PERCEIVED PANNUS GET EXPLANTED FOR VISUAL PATHOLOGY CONFIRMATION AND MICROSCOPIC DETERMINATION OF PANNUS VS ORGANIZED CLOT? WHAT IS THE RATE OF FALSE POSITIVES WITH CT BEING USED TO IDENTIFY PANNUS ENCROACHMENT WITH A MECHANICAL VALVE SUCH AS ON-X? THIS PAPER SUGGESTS A SENSITIVITY RATE OF 87.5% (FALSE NEGATIVE RATE OF 12.5%) AND SPECIFICITY OF 95.5% (FALSE POSITIVE RATE OF 4.5%). IS THERE FURTHER INFORMATION THAT YOU COULD PROVIDE?." NO RESPONSE WAS EVER RECEIVED FROM THE PUBLICATION AUTHOR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE EVALUATED AND THE COMPLAINT WILL BE RE-OPENED. MANUFACTURING RECORDS FOR THE ON-X AORTIC VALVE COULD NOT BE REVIEWED AS A SERIAL NUMBER IS UNAVAILABLE. THE SYSTEM COULD NOT BE QUERIED FOR POTENTIAL SERIAL NUMBERS SENT TO THE HOSPITAL AS A DEFINITIVE DATE OF IMPLANT IS UNKNOWN. A JOURNAL PUBLICATION RECEIVED INDICATED AN ON-X AORTIC VALVE AS DEMONSTRATING CHARACTERISTICS CONSISTENT WITH PANNUS CONSTRICTION. THE PUBLISHED CONCLUSION REQUIRED INTERPRETATION OF A NON-STANDARD IMAGING TECHNIQUE (CARDIAC COMPUTED TOMOGRAPHY, CT) ON A GROUP OF 4 MECHANICAL HEART VALVES WITH HIGHER THAN EXPECTED MTPG. THREE OF THE VALVES WERE NOT ON-X. NO IMAGES FOR THE ON-X VALVE CASE WERE PRESENTED IN THE PUBLICATION, NONE OF THE NUMERICAL DATA WAS SPECIFICALLY ATTRIBUTABLE TO THE ON-X VALVE BUT RATHER ONLY AS A MEMBER OF THE GROUP, NOR WAS THE CONCLUSION VERIFIED BY EXPLANTATION AND EXAMINATION. THE IDENTITY OF THE ON-X VALVE COULD NOT BE CONFIRMED AND QUERIES TO THE AUTHORS FOR MORE DETAILS WENT UNANSWERED. THERE IS TOO LITTLE OBJECTIVE AND VERIFIABLE INFORMATION TO DETERMINE THE VALIDITY OF THIS ANECDOTAL CLAIM. IN ANY CASE, PROSTHESIS PANNUS IS IDENTIFIED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE (IFU). THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
ACCORDING TO THE PUBLICATION "SUBPROSTHETIC PANNUS AFTER AORTIC VALVE REPLACEMENT SURGERY: CARDIAC CT FINDINGS CLINICAL FEATURES" BY DR. KICHANG HAD ET. AL., "SUBPROSTHETIC PANNUS WAS IDENTIFIED IN 17 PATIENTS (19%) AT CT. BASELINE PATIENT CHARACTERISTICS AND ECHOCARDIOGRAPHIC PARAMETERS ARE SUMMARIZED IN TABLE 1. IN PATIENTS WITH SUBPROSTHETIC PANNUS, THE TIME INTERVAL BETWEEN SURGERY AND CARDIAC CT, THE MTPG, THE PEAK PRESSURE GRADIENT, THE TRANSVALVULAR PEAK VELOCITY, AND THE LVEF WERE SIGNIFICANTLY HIGHER (P,.05) THAN IN PATIENTS WITHOUT PANNUS. THE INCIDENCE OF PANNUS FORMATION WAS MORE COMMON IN PATIENTS WITH SUPRA-ANNULAR VALVES THAN IN PATIENTS WITH INTRAANNULAR VALVES (26.5% [13 OF 49] VS 10.3% [FOUR OF 39]). SUBGROUP ANALYSIS IN PATIENTS WITH PANNUS. THE RESULTS OF THE SUBGROUP ANALYSIS FOR PATIENTS WITH PANNUS ARE SUMMARIZED IN TABLE 2. FOUR PATIENTS HAD A HIGH (40MM HG) MTPG AT ECHOCARDIOGRAPHY. THE COMMERCIAL NAMES OF THE AORTIC PROSTHETIC VALVES USED IN THESE FOUR PATIENTS WERE AS FOLLOWS: ON-X (= 1), ST UDE (N= 1), CARBOMEDICS (N= 1), AND EDWARDS MIRA (N= 1). AMONG THE CT PARAMETERS EVALUATED, THE RATIO OF ENCROACHMENT OF THE PROSTHETIC VALVULAR ORIFICE BY PANNUS WAS THE ONLY FACTOR THAT WAS HIGHER IN PATIENTS WITH HIGH MTPGS THAN IN PATIENTS WITH MTPGS OF LESS THAN 40 MMHG (42.7% 6 13.3 VS 7.6% 63.8,P=.012). THE SCATTERPLOT DEMONSTRATED THAT THERE WAS A POSITIVE CORRELATION BETWEEN THE ENCROACHMENT RATIO AND THE MTPG:THE HIGHER THE ENCROACHMENT RATIO, THE HIGHER THE MTPG (R= 0.709, P= .003) (FIG 2). IN THE PATIENTS WITH MTPGS OF LESS THAN 40 MM HG, THE ENCROACHMENT RATIO WAS LESS THAN 20%. THE ECHOCARDIOGRAPHIC PARAMETERS, INCLUDING TRANSVALVULAR PEAK VELOCITY AND PEAK PRESSURE GRADIENT, WERE SIGNIFICANTLY HIGHER IN PATIENTS WITH HIGH MTPGS. AMONG THE FOUR PATIENTS WITH HIGH MTPGS, THREE UNDERWENT REPEAT AORTIC VALVE REPLACEMENT, AND COMPARISON BETWEEN CARDIAC CT AND SURGICAL FINDINGS WAS PERFORMED. THE PANNUS SEEN ON RECONSTRUCTED CT IMAGES WAS SUCCESSFULLY CORRELATED WITH THE GROSS SURGICAL SPECIMEN IN ONE CASE (FIG 1F). SUPRA-ANNULAR PROSTHESES WERE USED IN 49 PATIENTS, AND INTRAANNULAR PROSTHESES WERE USED IN 39 PATIENTS. INTRA-ANNULAR PROSTHETIC VALVES WERE USED IN ALL OF THE FOUR PATIENTS WITH HIGH MTPGS, WHEREAS ALL THE OTHER PATIENTS WITH SUBPROSTHETIC PANNI HAD SUPRA-ANNULAR PROSTHESES (FIG 3)."
ACCORDING TO THE PUBLICATION "SUBPROSTHETIC PANNUS AFTER AORTIC VALVE REPLACEMENT SURGERY: CARDIAC CT FINDINGS CLINICAL FEATURES" BY DR. KICHANG HAD ET. AL., "SUBPROSTHETIC PANNUS WAS IDENTIFIED IN 17 PATIENTS (19%) AT CT. BASELINE PATIENT CHARACTERISTICS AND ECHOCARDIOGRAPHIC PARAMETERS ARE SUMMARIZED. IN PATIENTS WITH SUBPROSTHETIC PANNUS, THE TIME INTERVAL BETWEEN SURGERY AND CARDIAC CT, THE MTPG, THE PEAK PRESSURE GRADIENT, THE TRANSVALVULAR PEAK VELOCITY, AND THE LVEF WERE SIGNIFICANTLY HIGHER (P,.05) THAN IN PATIENTS WITHOUT PANNUS. THE INCIDENCE OF PANNUS FORMATION WAS MORE COMMON IN PATIENTS WITH SUPRA-ANNULAR VALVES THAN IN PATIENTS WITH INTRAANNULAR VALVES (26.5% [13 OF 49] VS 10.3% [FOUR OF 39]). SUBGROUP ANALYSIS IN PATIENTS WITH PANNUS. THE RESULTS OF THE SUBGROUP ANALYSIS FOR PATIENTS WITH PANNUS ARE SUMMARIZED. FOUR PATIENTS HAD A HIGH (40 MM HG) MTPG AT ECHOCARDIOGRAPHY. THE COMMERCIAL NAMES OF THE AORTIC PROSTHETIC VALVES USED IN THESE FOUR PATIENTS WERE AS FOLLOWS: ON-X (= 1), ST JUDE (N= 1), CARBOMEDICS (N= 1), AND EDWARDS MIRA (N= 1). AMONG THE CT PARAMETERS EVALUATED, THE RATIO OF ENCROACHMENT OF THE PROSTHETIC VALVULAR ORIFICE BY PANNUS WAS THE ONLY FACTOR THAT WAS HIGHER IN PATIENTS WITH HIGH MTPGS THAN IN PATIENTS WITH MTPGS OF LESS THAN 40 MMHG (42.7% 6 13.3 VS 7.6% 63.8,P=.012). THE SCATTERPLOT DEMONSTRATED THAT THERE WAS A POSITIVE CORRELATION BETWEEN THE ENCROACHMENT RATIO AND THE MTPG:THE HIGHER THE ENCROACHMENT RATIO, THE HIGHER THE MTPG (R= 0.709, P= .003). IN THE PATIENTS WITH MTPGS OF LESS THAN 40 MM HG, THE ENCROACHMENT RATIO WAS LESS THAN 20%. THE ECHOCARDIOGRAPHIC PARAMETERS, INCLUDING TRANSVALVULAR PEAK VELOCITY AND PEAK PRESSURE GRADIENT, WERE SIGNIFICANTLY HIGHER IN PATIENTS WITH HIGH MTPGS. AMONG THE FOUR PATIENTS WITH HIGH MTPGS, THREE UNDERWENT REPEAT AORTIC VALVE REPLACEMENT, AND COMPARISON BETWEEN CARDIAC CT AND SURGICAL FINDINGS WAS PERFORMED. THE PANNUS SEEN ON RECONSTRUCTED CT IMAGES WAS SUCCESSFULLY CORRELATED WITH THE GROSS SURGICAL SPECIMEN IN ONE CASE. SUPRA-ANNULAR PROSTHESES WERE USED IN 49 PATIENTS, AND INTRAANNULAR PROSTHESES WERE USED IN 39 PATIENTS. INTRA-ANNULAR PROSTHETIC VALVES WERE USED IN ALL OF THE FOUR PATIENTS WITH HIGH MTPGS, WHEREAS ALL THE OTHER PATIENTS WITH SUBPROSTHETIC PANNI HAD SUPRA-ANNULAR PROSTHESES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768985 | ON-X AORTIC HEART VALVE UNKNOWN CONFIGURATION | HEART-VALVE, MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXA UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |