MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA CP C7 W V3 GWRU SET, US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Sepsis (2067)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.Instructions for use for the related event are as follows: section: warnings and cautions ¿make sure there is no bleeding at the transition from the repositioning sheath to the internal jugular vein.Close and dress the wound ¿be sure that the stopcock on the repositioning sheath is always kept in the closed position.Significant bleed back can result if the stopcock is open.¿ ¿make sure there is no bleeding at the transition from the repositioning sheath to the femoral vein.Close and dress the wound.¿ section: table 3.2 impella catheter components ¿the infusion filter prevents bacterial contamination and air from entering the purge lumen.¿ section: warnings & cautions: warnings ¿to reduce the possibility of fibers being drawn into the impella, customers should avoid exposing the inlet and cannula section of the impella heart pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers.¿ this report is being filed as part of a retrospective review of historical records.
Event or Problem Description
Complainant reported that the patient was attempting to be placed on impella cp due to the non-st elevated myocardial infarction, cath showed 90% calcified left main, 95% ostial left anterior descending, 85% circumflex, 99% mid right coronary artery.Chronic kidney disease creat.1.96, hypertension, coronary artery disease, heart failure, ejection fraction 20%, renal insufficiency and surgical turndown.The patient's primary indication was noted as high-risk percutaneous coronary intervention.While on support, on (b)(6) 2021, the complainant reported the patient had a small hematoma noted in cath lab after the peel away sheath removed, and repositioning sheath placed.Perclose sutures were tightened, pressure was held, and femstop added.Standard care was presented to the patient.Standard care is not medical intervention.While on support, on (b)(6) 2021, the complainant reported the treatment is moving towards sepsis, white blood count¿s 8.4, low grade temp 99 all day.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20005237
• Report Number: 1220648-2024-15513
• Device Sequence Number: 20673092
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1452125(17)211031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IMPELLA CP C7 W V3 GWRU SET, US
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1452125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White