AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
Report
- Report Number
- 2135147-2024-05268
- Event Type
- Injury
- Date Received
- October 24, 2024
- Date of Event
- January 1, 2008
- Report Date
- January 2, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MLV
- PMA / PMN Number
- P000039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: EVENT DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED " TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS "
B3: EVENT DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED " TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS. " SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER SEPTAL OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION. COMPLICATIONS REPORTED INCLUDED UNEXPECTED MEDICAL INTERVENTION (SNARE), ARRHYTHMIA, THROMBUS, DEVICE EMBOLIZATION, DEFORMATION (COBRA), RESIDUAL SHUNT, THROMBUS; 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 INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING.
THE ARTICLE, "TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS", WAS REVIEWED THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ANALYSIS OF ALL CASES OF MULTIPLE ATRIAL SEPTAL DEFECTS (ASDS) MANAGED USING MORE THAN ONE ATRIAL SEPTAL OCCLUDER. DEVICES INCLUDED AMPLATZER CRIBRIFORM AND AMPLATZER SEPTAL OCCLUDER. THE ARTICLE CONCLUDED THAT USE OF MULTIPLE DEVICES FOR CLOSING MULTIPLE ATRIAL SEPTAL DEFECTS (MASDS) IS FEASIBLE WITH GOOD TECHNICAL SUCCESS. ECHOCARDIOGRAPHY AND BALLOON INTERROGATION ARE THE KEYS FOR SUCCESS. SIMULTANEOUS DEPLOYMENT IS OFTEN NEEDED AND SEQUENTIAL DELIVERY IS FEASIBLE RARELY IF THE DEFECTS ARE FAR APART. MINOR RESIDUAL LEAKS ARE COMMON BUT IMPROVE ON FOLLOW-UP. THERE ARE NO SIGNIFICANT NEW COMPLICATIONS ON LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOTHANDAM SIVAKUMAR, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIOVASCULAR DISEASES, THE MADRAS MEDICAL MISSION, NO 4A, DR J J NAGAR, MOGAPPAIR, CHENNAI - 600 037, TAMIL NADU, INDIA, WITH CORRESPONDING E-MAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2008 TO DECEMBER 2019. A TOTAL OF 25 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 33.92 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION.
THE ARTICLE, "TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS", WAS REVIEWED THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ANALYSIS OF ALL CASES OF MULTIPLE ATRIAL SEPTAL DEFECTS (ASDS) MANAGED USING MORE THAN ONE ATRIAL SEPTAL OCCLUDER. DEVICES INCLUDED AMPLATZER CRIBIFORM OCCLUDER, AMPLATZER SEPTAL OCCLUDER, FIGULLA SEPTAL OCCLUDER, CERA ASD OCCLUDER. THE ARTICLE CONCLUDED THAT USE OF MULTIPLE DEVICES FOR CLOSING MULTIPLE ATRIAL SEPTAL DEFECTS (MASDS) IS FEASIBLE WITH GOOD TECHNICAL SUCCESS. ECHOCARDIOGRAPHY AND BALLOON INTERROGATION ARE THE KEYS FOR SUCCESS. SIMULTANEOUS DEPLOYMENT IS OFTEN NEEDED AND SEQUENTIAL DELIVERY IS FEASIBLE RARELY IF THE DEFECTS ARE FAR APART. MINOR RESIDUAL LEAKS ARE COMMON BUT IMPROVE ON FOLLOW-UP. THERE ARE NO SIGNIFICANT NEW COMPLICATIONS ON LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOTHANDAM SIVAKUMAR, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIOVASCULAR DISEASES, THE MADRAS MEDICAL MISSION, NO 4A, DR J J NAGAR, MOGAPPAIR, CHENNAI - 600 037, TAMIL NADU, INDIA, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2008 TO DECEMBER 2019. A TOTAL OF 25 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 33.92 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2564867 | AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM | TRANSCATHETER SEPTAL OCCLUDER | MLV | ABBOTT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |