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 Code	Insufficient Information (4580)
Date of Event	10/20/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported through the research article: "comparison of outcomes in patients requiring mechanical circulatory support who received cangrelor in addition to anticoagulation versus anticoagulation alone" that centrimag may be associated with major bleeding, thrombosis, stroke, and death.This study evaluated safety of cangrelor administered concurrently with heparin or bivalirudin in patients implanted with mechanical circulatory support (mcs) consecutively admitted between 01jan2016 and 20oct2020.The primary outcome of the study was major bleeding, defined as clinically overt bleeding associated with hemoglobin fall >= 2 g/dl within 24-hours, > 20 ml/kg measurable blood loss within 24 hours, >= 10 ml/kg pack rbc transfusions within 24 hours; retroperitoneal bleeding, pulmonary bleeding, bleeding involving the central nervous system, or bleeding requiring surgical intervention.Secondary outcomes included major bleeding based on antithrombotic modality (single-, double-, or triple-antithrombotic therapy), incidence of stent thrombosis (st), thrombotic events including deep vein thrombosis, pulmonary embolism, embolic stroke, extracorporeal membrane oxygenation (ecmo) or oxygenator replacement due to clotting, continuous renal replacement therapy filter clotting, or in-stent rethrombosis.A total of 68 patients were eligible for study inclusion and split into two cohorts: 29 patients received cangrelor and 39 did not, with all patients having a cangrelor-free period.Patients were mostly male (73.5%) with a median age of 59 years.A total of 13 patients were on centrimag, with breakdown of all device types and cannulation sites as follows: 28 patients were cannulated on venoarterial-ecmo (va-ecmo), with 23 on central va-ecmo and 5 on peripheral va-ecmo.One patient transferred to vevovenous-ecmo (vv-ecmo) and was converted to va-ecmo on admission.Six patients were on percutaneous right ventricular assist device (rvad) support with oxygenation (oxy-rvad).One patient required vv-ecmo with impella.Ten patients were on impella cp, 21 were on impella 5.0 or 5.5, and 2 patients converted from impella cp to 5.0.One patient was on a central biventricular vad (bivad).One patient had a durable left vad (lvad) and required temporary rvad after implant.It was not specified in the study how the centrimag device was cannulated or if oxygenation was utilized with the device.Results found 12 patients (41.4%) on cangrelor had a major bleeding event, compared with 24 patients (35.8%) who had a major bleeding events during cangrelor-free periods.Use of cangrelor was not associated with a statistically significant increase in major bleeding (p = 0.262), nor was the use of aspirin (p = 0.983).When compared to anticoagulation alone, dual- and triple-antithrombotic therapies were not associated with an increased risk of major bleeding (p = 0.332 and p = 0.963, respectively).Subgroup analysis of device type and cannulation site revealed no statistically significant difference in major bleeding among groups.The cangrelor cohort had higher rates of a hemoglobin decrease of >= 2 g/dl, transfusion requirement >= 10 ml/kg, and thrombosis, whereas the cohort who did not received cangrelor had a higher rate of bleeding requiring surgery and critical site bleeding.Central va-ecmo patients had a higher rate of major bleeding compared to impella or peripheral va-ecmo; however, this was statistically nonsignificant when comparing central cannulation to all other cannulations.When factoring in cangrelor use, rates of major bleeding were higher during cangrelor-free periods in patients on central or peripheral va-ecmo.Impella, oxy-rvad, and vv-ecmo patients had higher rates of bleeding while on cangrelor than during cangrelor-free periods.Two instances of st occurred but it was noted these occurred while patients were not on cangrelor.One patient with rvad support suffered from st when transitioning from cangrelor to ticagrelor and was discharged home.One patient suffered an st when decannulated from impella support and transitioned from cangrelor to clopidogrel; st occurred after 10 days on clopidogrel, and the patient required impella support and subsequent va-ecmo but later passed away.It was also noted that 16 patients passed away while on mcs; causes of death were not provided.The study concluded that patients receiving cangrelor were not at a statistically higher risk of major bleeding compared to patients not receiving cangrelor in patients on temporary mcs; however, given the small patient population, it is likely the study was unable to detect the true difference in bleeding risk.
Additional Manufacturer Narrative
Sections a and d: specific patient information and device serial number are documented as unknown.Details are listed in the attached article.Device was implanted at time of event.Section b2: specific death date is documented as unknown.Details are listed in the attached article section b3: date of event has been entered as 20-oct-2020 as the patients were implanted between 01-jan-2016 and 20-oct-2020.Author information: martin, t.C., duewell, b.E., juul, j.J., rinka, j.R.G., rein, l., & feih, j.T.(2024).Comparison of outcomes in patients requiring mechanical circulatory support who received cangrelor in addition to anticoagulation versus anticoagulation alone.Journal of cardiothoracic and vascular anesthesia, 38(6), 1328¿1336.Https://doi.Org/10.1053/j.Jvca.2024.02.039.Froedtert hospital, milwaukee, wi; concordia university wisconsin, mequon, wi; medical college of wisconsin, milwaukee, wi manufacturer's investigation conclusion: a direct correlation between centrimag blood pumps and the reported events could not be conclusively determined through this evaluation.The centrimag blood pump instructions for use (ifu) lists adverse events that may be associated with the centrimag circulatory support system, including death, under ¿adverse events¿.This ifu also provides the following warnings and cautions: 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.Ifu caution #15: a backup centrimag pump, console, motor and accessories should be available for use.The current revisions of the instructions for use (ifu) and operation manual can also be found on the electronic ifu (eifu) page of the abbott website.The lot numbers of the devices in use were not provided.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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50223066
• Report Number: 3003306248-2026-00264
• Device Sequence Number: 5521476
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 07/28/2026
• Initial Report FDA Received Date: 08/12/2026
• 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: Death
• Patient Sex: Unknown