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

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that during implant of a heartmate 3 left ventricular assist device (lvad) and a centrimag right ventricular assist device (rvad), the patient developed an intraoperative right middle cerebral artery/internal carotid artery occlusion which resulted in hemispheric stroke.Medical management and optimization was performed including blood pressure controller and hypertonic saline infusion.Lvad mfr # 2916596-2022-14520.

Event Description

It was reported that the patient was in the intensive care unit (icu) on both a left ventricular assist device (lvad) and right ventricular assist device (rvad).Log files captured persistent low flow events for the patient.The flow was noted as low as 0.4 liters per minute (lpm) and the majority of these low flow events were in the presence of elevated pulsatility index (pi) values.It was reported that the patient passed away on (b)(6) 2022 due to intraoperative right middle cerebral artery/internal carotid artery occlusion which resulted in hemispheric stroke.Additional information was received that the stroke occurred during implant on (b)(6) 2022.The patient was implanted with a centrimag rvad on the same day as lvad implant for pre-existing right heart failure.Medical management and optimization were performed, including blood pressure control and hypertonic saline infusion.Lvad mfr # 2916596-2022-14520.

Manufacturer Narrative

The patient's death is reported against the lvad - mfr # 2916596-2022-14520.Section d4: lot number was requested but was not provided.Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported stroke and patient outcome could not be conclusively established through this evaluation.The centrimag pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The us (united states) centrimag blood pump instructions for use (ifu) (rev.09) lists adverse events that may be associated with the centrimag circulatory support system, including thromboembolism, neurologic dysfunction, 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.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: 16123452
• MDR Text Key: 306986128
• Report Number: 3003306248-2023-00004
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/26/2023
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 85 KG