IMPELLA
Report
- Report Number
- 1220648-2026-06045
- Event Type
- Injury
- Date Received
- March 30, 2026
- Date of Event
- March 20, 2026
- Report Date
- May 20, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D6B. EXPLANT DATE WAS RECEIVED AND ADDED.
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
AN UPDATED CLINICAL ASSESSMENT WAS COMPLETED AND DOCUMENTED IN B5 (EVENT DESCRIPTION) BASED ON ADDITIONAL INFORMATION THAT WAS RECEIVED (PREVIOUSLY REPORTED IN FOLLOW-UP 3). DEVICE STATUS. ADDITIONALLY, THE DEVICE WAS RECEIVED, AND AN EVALUATION/ANALYSIS IS CURRENTLY IN PROGRESS. ACCORDINGLY, SECTION D9 HAS BEEN UPDATED TO REFLECT THE DEVICE RECEIPT DATE. SECTION H6 (INVESTIGATION TYPE, FINDINGS, AND CONCLUSION) HAS ALSO BEEN UPDATED TO ALIGN WITH THIS INFORMATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
B5 AND H6 UPDATED BASED ON THE ADDITIONAL INFORMATION.
THE PATIENT STATUS AFTER EXPLANT WAS SURVIVED.
CORRECTED DATA: D4 SERIAL AND UDI NUMBERS UPDATED. INVESTIGATION SUMMARY: THROMBOSIS: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PERI-PROCEDURAL ADVERSE EVENT/ MAJOR BLEED: THE CAUSE OF BLEEDING WAS NOT DETERMINED DUE INSUFFICIENT CLINICAL DETAILS AND OCCURRED PRE IMPELLA SUPPORT.
CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT DIRECT SURGICAL APPROACH IN A 77-YEAR-OLD FEMALE PATIENT PRESENTING WITH POSTCARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME (PCCS/LCOS), SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. SHE WAS TAKEN TO THE OPERATING ROOM FOR MITRAL VALVE REPLACEMENT AND TRICUSPID REPAIR ON (B)(6), FOLLOWED BY PERIPHERAL VA-ECMO CANNULATION LATER THAT EVENING. SEVERE AORTIC INSUFFICIENCY WAS NOTED, AND THE PATIENT WAS PLANNED FOR REOPERATION WITH AORTIC VALVE REPLACEMENT AND DIRECT IMPELLA 5.5 PLACEMENT. THE IMPELLA 5.5 WAS PLACED DIRECTLY INTO THE AORTA IN STANDARD FASHION, AND THE PATIENT WAS TRANSITIONED BACK TO PERIPHERAL VA-ECMO. DURING THE SURGERY, THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS INCLUDING PACKED RED BLOOD CELLS, FRESH FROZEN PLASMA, PLATELETS, AND CRYOPRECIPITATE FOR SURGICAL BLEEDING. THE BLEEDING WAS NOT SPECIFICALLY ATTRIBUTED TO THE IMPELLA PER THE PHYSICIAN. A CONTRIBUTING FACTOR WAS THE PATIENT'S POSTOPERATIVE SURGICAL STATUS REQUIRING MULTIPLE BLOOD PRODUCT TRANSFUSIONS. THE PATIENT REMAINED ON SUPPORT. THE REPORTED MAJOR BLEED REQUIRING BLOOD TRANSFUSION IS CONSISTENT WITH PERIOPERATIVE AND ACCESS-RELATED COMPLICATIONS IN THE SETTING OF CARDIAC SURGERY AND SYSTEMIC ANTICOAGULATION REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT.
AN IMPELLA 5.5 DEVICE WAS INSERTED VIA A RIGHT DIRECT SURGICAL APPROACH IN A 77-YEAR-OLD FEMALE PATIENT PRESENTING WITH POST-CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME (PCCS/LCOS), CLASSIFIED AS SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. SHE UNDERWENT MITRAL VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR ON MARCH 19, FOLLOWED BY PERIPHERAL VA-ECMO CANNULATION LATER THAT EVENING. SEVERE AORTIC INSUFFICIENCY WAS IDENTIFIED, AND THE PATIENT WAS PLANNED FOR REOPERATION WITH AORTIC VALVE REPLACEMENT AND DIRECT IMPELLA 5.5 PLACEMENT. THE IMPELLA 5.5 WAS PLACED DIRECTLY INTO THE AORTA IN STANDARD FASHION, AND THE PATIENT WAS TRANSITIONED BACK TO PERIPHERAL VA-ECMO. DURING SURGERY, THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCT TRANSFUSIONS, INCLUDING PACKED RED BLOOD CELLS, FRESH FROZEN PLASMA, PLATELETS, AND CRYOPRECIPITATE, FOR SURGICAL BLEEDING. PER THE PHYSICIAN, THE BLEEDING WAS NOT SPECIFICALLY ATTRIBUTED TO THE IMPELLA DEVICE. A CONTRIBUTING FACTOR WAS THE PATIENT¿S POSTOPERATIVE SURGICAL STATUS, WHICH REQUIRED MULTIPLE TRANSFUSIONS. THE PATIENT REMAINED ON MECHANICAL CIRCULATORY SUPPORT FOLLOWING THE PROCEDURE. THE REPORTED MAJOR BLEEDING REQUIRING TRANSFUSION IS CONSISTENT WITH PERIOPERATIVE AND ACCESS-RELATED COMPLICATIONS IN THE SETTING OF CARDIAC SURGERY AND THE SYSTEMIC ANTICOAGULATION REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE PATIENT WAS SUBSEQUENTLY WEANED FROM SUPPORT AND EXPLANTED. POST-EXPLANT, THE SURGICAL TEAM NOTED THE PRESENCE OF A CLOT NEAR THE OUTFLOW CAGE OF THE DEVICE. IN THE SETTING OF POST-CARDIOTOMY CARDIOGENIC SHOCK, VA-ECMO SUPPORT, AND RECENT CARDIAC SURGERY, FACTORS SUCH AS BLOOD STASIS, SYSTEMIC INFLAMMATION, COAGULOPATHY, AND TEMPORARY INTERRUPTIONS OR ADJUSTMENTS IN ANTICOAGULATION MAY CONTRIBUTE TO THROMBUS FORMATION WITHIN OR NEAR THE DEVICE. THE PRESENCE OF THROMBUS NEAR THE OUTFLOW CAGE FOLLOWING EXPLANT IS CONSISTENT WITH THESE KNOWN CLINICAL AND PHYSIOLOGIC RISK FACTORS.
PATIENT WEANED AND EXPLANTED. POST EXPLANT, SURGICAL TEAM NOTICED A CLOT NEAR OUTFLOW CAGE OF DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 345109 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2027823541 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |