MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Coma (2417); Hemorrhagic Stroke (4417)

Event Date 02/07/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation conclusion: a correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was found unresponsive on (b)(6) 2022.They were admitted to the emergency room (er) where they were intubated.The patient had a right eye hematoma and unequal pupils.Upon arrival, the patient was a 6 on the glasgow coma scale (gcs).They were given blood thinners to reverse anticoagulation.The patient's gcs score declined to 3 during their admittance.Head imaging revealed a large intraparenchymal and subarachnoid hemorrhage in the left frontoparietal region with mass effect and midline shift.Repeat imaging overnight showed ongoing bleeding despite international normalized ratio (inr) reversal.The patient lacked any intact neuro reflexes.The ventricular assist device (vad) was interrogated on (b)(6) 2022 morning and the patient was found to be without any lvad alarms.The family withdrew care and the patient passed away on (b)(6) 2022.The vad and its peripheral equipment will not be returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: a correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was found unresponsive on (b)(6) 2022.They were admitted to the emergency room (er) where they were intubated.The patient had a right eye hematoma and unequal pupils.Upon arrival, the patient was a 6 on the glasgow coma scale (gcs).They were given blood thinners to reverse anticoagulation.The patient's gcs score declined to 3 during their admittance.Head imaging revealed a large intraparenchymal and subarachnoid hemorrhage in the left frontoparietal region with mass effect and midline shift.Repeat imaging overnight showed ongoing bleeding despite international normalized ratio (inr) reversal.The patient lacked any intact neuro reflexes.The ventricular assist device (vad) was interrogated on (b)(6) 2022 morning and the patient was found to be without any lvad alarms.The family withdrew care and the patient passed away on (b)(6) 2022.The vad and its peripheral equipment will not be returned.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13561014
• MDR Text Key: 285834869
• Report Number: 2916596-2022-00899
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6257935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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): Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 134 KG