MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE

Model Number	102953
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d4: device lot number was not provided, so the expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) and had a history of recent mitral valve replacement (mvr), stents, and thrombus on the mitral valve (mv) pre-implant.A centrimag right ventricular assist device (rvad) via a third-party catheter (protek duo) was placed due to right ventricular (rv) dysfunction.On (b)(6) 2025, the patient passed away due to a large mid-cerebral artery (mca) stroke.
Event or Problem Description
It was additionally reported that the mca stroke was an mca lesion that was followed by hemorrhagic stroke after mechanical thrombectomy of the left middle cerebral artery occlusion, which was complicated by bleeding requiring coil embolization.The stroke was identified via computed tomography (ct) scan.The centrimag was not thought to have contribute to the mca stroke.The patient was unresponsive to commands postoperatively.The site could not confirm if there was any malfunction of the outflow graft bend relief that indicated why it was not used during lvad implant.The death was not considered to be device or therapy related, and the lvad and centrimag operated as intended.
Additional Manufacturer Narrative
H8 - usage of device - correction.Manufacturer¿s investigation conclusion: a direct correlation between the reported events and the centrimag pump could not be conclusively established through this evaluation.The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2025 and after implant was transitioned from cardiopulmonary bypass to a centrimag pump for right ventricular assist device (rvad) support.The rvad speed was set to 4700 revolutions per minute with flow of 3.7 liters per minute.The patient¿s heart rate was 77 beats per minute with blood pressure of 76 systolic/66 diastolic (mean 73) millimeters of mercury (mmhg).After the operation, the patient was found to be unresponsive to commands, and a computed tomography scan reportedly showed a middle cerebral artery (mca) stroke.A mechanical thrombectomy was performed and was complicated by bleeding, which required coil embolization.The patient ultimately expired on (b)(6) 2025 due to the mca stroke.It was reported that the patient¿s outcome was not considered to be device or therapy related, and the rvad reportedly operated as intended.The centrimag pump was not returned for evaluation.The lot number of the product was not reported.The centrimag blood pump instructions for use (ifu) (rev.C) lists adverse events that may be associated with the centrimag circulatory support system, including thromboembolism (venous or arterial non-central nervous system), neurologic dysfunction, bleeding, and death, under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.The current revisions of the instructions for use (ifu) and operation manual can also be found on the electronic ifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Common Device Name: BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22482855
• Report Number: 3003306248-2025-00211
• Device Sequence Number: 15620325
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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 Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White