PORTICO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2135147-2025-07807
- Event Type
- Injury
- Date Received
- December 30, 2025
- Date of Event
- January 1, 2016
- Report Date
- February 3, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- PMA / PMN Number
- P190023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: EFFECT OF MITRAL ANNULAR CALCIFICATION ON OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT B3: EVENT DATE WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, HEMODIALYSIS, ATRIAL FIBRILLATION, AND HEART BLOCK. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (PACEMAKER), STROKE, HEART BLOCK; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B3: EVENT DATE IS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: EFFECT OF MITRAL ANNULAR CALCIFICATION ON OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT.
THE ARTICLE, "EFFECT OF MITRAL ANNULAR CALCIFICATION ON OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE IMPACT OF MITRAL ANNULAR CALCIFICATION (MAC) SEVERITY AND ANATOMICAL DISTRIBUTION ON CLINICAL OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DEVICES THAT WERE INCLUDED IN THE STUDY WERE COREVALVE/EVOLUT R/PRO, SAPIEN 3/XT, ACURATE NEO, PORTICO, AND LOTUS EDGE. THE ARTICLE CONCLUDED THAT MAC LOCALIZATION IN THE A3 SEGMENT IS INDEPENDENTLY ASSOCIATED WITH PACEMAKER IMPLANTATION DUE TO COMPLETE ATRIAL VENTRICULAR BLOCK (CAVB) FOLLOWING TAVR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOICHI MAEDA, DEPARTMENT OF CARDIOVASCULAR SURGERY, THE UNIVERSITY OF OSAKA GRADUATE SCHOOL OF MEDICINE, 2-2 YAMADAOKA, SUITA, OSAKA, 565-0871, JAPAN, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WHO UNDERWENT TAVR BETWEEN 01 JANUARY 2016 AND 31 DECEMBER 2021. A TOTAL OF 642 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. IN THE NO MAC GROUP, THE AVERAGE AGE WAS 84 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. IN THE MILD/MODERATE MAC GROUP, THE AVERAGE AGE WAS 84 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. IN THE SEVERE MAC GROUP, THE AVERAGE AGE WAS 85 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED IN THE STUDY WERE HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, HEMODIALYSIS, ATRIAL FIBRILLATION, AND HEART BLOCK.
THE ARTICLE, "EFFECT OF MITRAL ANNULAR CALCIFICATION ON OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE IMPACT OF MITRAL ANNULAR CALCIFICATION (MAC) SEVERITY AND ANATOMICAL DISTRIBUTION ON CLINICAL OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DEVICES THAT WERE INCLUDED IN THE STUDY WERE COREVALVE/EVOLUT R/PRO, SAPIEN 3/XT, ACURATE NEO, PORTICO, AND LOTUS EDGE. THE ARTICLE CONCLUDED THAT MAC LOCALIZATION IN THE A3 SEGMENT IS INDEPENDENTLY ASSOCIATED WITH PACEMAKER IMPLANTATION DUE TO COMPLETE ATRIAL VENTRICULAR BLOCK (CAVB) FOLLOWING TAVR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOICHI MAEDA, DEPARTMENT OF CARDIOVASCULAR SURGERY, THE UNIVERSITY OF OSAKA GRADUATE SCHOOL OF MEDICINE, 2-2 YAMADAOKA, SUITA, OSAKA, 565-0871, JAPAN, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WHO UNDERWENT TAVR BETWEEN 01 JANUARY 2016 AND 31 DECEMBER 2021. A TOTAL OF 642 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. IN THE NO MAC GROUP, THE AVERAGE AGE WAS 84 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. IN THE MILD/MODERATE MAC GROUP, THE AVERAGE AGE WAS 84 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. IN THE SEVERE MAC GROUP, THE AVERAGE AGE WAS 85 YEARS OLD, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED IN THE STUDY WERE HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, HEMODIALYSIS, ATRIAL FIBRILLATION, AND HEART BLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2272988 | PORTICO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | UNK PORTICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability| L| R |