MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related mfr# 2916596-2024-00267 and mfr# 2916596-2024-00268.It was reported that centrimag may be associated with thrombosis and stroke.The research article ¿single center experience with durable continuous flow single ventricle assist device: a viable option in fontan circulatory failure¿ detailed a single-center retrospective study evaluating 9 patients with fontan circulation implanted with a single ventricular assist device (svad) between mar2017 and jun2022.A total of 7 patients were implanted with hm3, and two were implanted with hvad.It was noted that one patient was initially supported on impella but was transitioned to hm3.It was also noted one patient was initially supported on centrimag but was transitioned within 48 hours to hvad.It was noted that the patient who transitioned from centrimag to hvad experienced pump thrombosis and a hemorrhagic stroke; it was not reported in the article if these events occurred prior to transitioning devices.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported pump thrombosis could not be confirmed through this evaluation, as no images were submitted for review and the device was not returned for evaluation.In addition, a direct correlation between the centrimag device and the reported hemorrhagic stroke could not be conclusively established through this evaluation.The centrimag device lot number and other specific case/patient information are not available.No product was evaluated under this complaint.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu), rev.B, lists bleeding and thromboembolism as adverse events that may be associated with the centrimag circulatory support system 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.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18551282
• MDR Text Key: 333334853
• Report Number: 3003306248-2024-00012
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention