MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

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

Patient Problems Syncope (1610); Fall (1848); Hematoma (1884); Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Hematuria (2558); Syncope/Fainting (4411); Hemorrhagic Stroke (4417); Limb Fracture (4518)

Event Date 11/27/2020

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

It was reported that the patient presented to the emergency department (ed) with syncope and a ground level fall that resulted in a superficial abrasion with bleeding controlled over the posterior scalp.A head computed tomography (ct) showed acute subarachnoid hemorrhage and a scalp hematoma involving the posterior left scalp soft tissues.Neuro and cardiac surgery were consulted and it was agreed upon to reverse the patient's anticoagulation with 10mg of vitamin k.The patient international normalized ratio (inr) was 2.2 at presentation to the ed with partial thromboplastin time (ptt) at 28.8 seconds.Additional information communicated on 07dec2020 reported that the patient's bleeding was treated with vitamin k.It was additionally reported that the patient mental status was described as alert and oriented to person, place, and time and he is at his baseline.The patient activity level is described as spontaneous movement with full range of motion and strength.

Event Description

Additionally, on (b)(6)2020 the patient was rising from a chair when they suddenly felt lightheaded, fell, and hit their head on the floor.The patient reported a brief loss of consciousness.A computed tomography (ct) taken on (b)(6)2020 revealed a subarachnoid hemorrhage.Two repeat cts on (b)(6)2020 revealed a mildly increasing hemorrhage while cts performed from (b)(6)2020 revealed a stable hemorrhage.Cts on (b)(6)2020 and (b)(6)2020 revealed continuing evolution/resorption of previously seen bilateral subarachnoid hemorrhages.A ct on (b)(6)2020 revealed previously seen foci of subarachnoid hemorrhage were resolved.No new hemorrhage or acute intracranial abnormality was seen on three follow-up cts performed (b)(6)2020.The patient's hemoglobin on (b)(6)2020 was 11.8 g/dl and on (b)(6)2020 was 11.2 g/dl.Their hemoglobin remained in the 10-11 range until (b)(6)2020 when it dropped further.Hematuria was a concomitant problem.On (b)(6)2020 the patient was transfused with 316 ml of plasma.Additionally, the patient reportedly slid off of his bed to the floor on (b)(6)2020.The patient landed on his buttocks and scraped his right elbow, but denied hitting his head.He also denied any head pain.On (b)(6)2020, the patient was being assisted by a nurse while walking to the bathroom, experienced lightheadedness, and fell while assisted.The patient did not hit his head during this fall.Additionally, the patient was assisted by a nurse for a hallway walk with his gait belt, walker, and non-slip socks on (b)(6)2020.While walking, the patient said "my knee" and began to lean forward as he was held up by his gait belt to help with balance.The patient continued to lose control of his balance and was lowered to the floor.The nurse held onto his head with one hand and used the other to guide the patient to the floor.The patient was lowered to the floor by first being lowered to his knee and then being lowered to his buttock.The patient did not forcefully hit the floor, nor did he hit his head.The nurse called for assistance and the patient was reassessed with neuro checks, assisted up to a recliner, pushed back to his room, and placed in his bed.The patient's vital signs were obtained, pain was reassessed, hm3 connections were checked, flows were checked, blood glucose was obtained, pulses were check via doppler, and pulses were marked with skin markers.Additionally, the patient's skin was marked at his previous ecchymotic/hematoma site that is on his left pelvis and left lower extremity.There were no changes from the patient's old ecchymotic areas from previous falls.The patient was only noted with a minor let knee skin abrasion from the fall.Ct pulmonary angiogram (ctpa) showed subtle cortical irregularity along the superior aspect of the left femoral neck.The findings were suspicious for an early nondisplaced femoral neck fracture.A bone scan re-demonstrated a large left gluteal musculature and left inguinal hernia the patient's hemoglobin level was 10.6g/dl on (b)(6)2020, 6.4g/dl on (b)(6)2020, 6.6g/dl on (b)(6)2020, and 11.5g/dl on (b)(6)2021.The patient was transfused with 600ml of red blood cells (rbcs) on (b)(6)2020, 218.8ml of rbcs on (b)(6)2020, 303.6ml of rbcs on (b)(6)2020, and 358.3ml rbcs on (b)(6)2020.A lower extremity computed tomography (ct) scan on (b)(6)2020 revealed a hematoma in the region of the left gluteal musculature.A subsequent ct on (b)(6)2020 showed a decrease in the size of the hematoma.Multiple daily neuro checks were performed from (b)(6)2020 through (b)(6)2021.

Event Description

It was reported, that on (b)(6) 2020 the patient's hemoglobin was 10.5g/dl.The reference hemoglobin level was 12.1g/dl on (b)(6) 2020.The lowest hemoglobin level, during the event was 10.5g/dl on (b)(6) 2020.This bleeding event, which began on (b)(6) 2020, reportedly resolved without sequelae on (b)(6) 2020.Additionally, it was reported, that the bone scan that was taken on (b)(6) 2020 revealed, no evidence of left hip fracture, but did reveal evidence of a fracture of the left fourth rib.The attending physician determined, that the patient had deconditioning and weakness related their prolonged hospitalization.Physical therapy and occupational therapy treatments that were already in place continued.Neuro checks were ordered for the patient, during every nursing shift.The attending doctor also recommended elevation of the left side and ice as needed.On (b)(6) 2021, the patient was progressing well.And was discharged to inpatient rehabilitation for continued rehab.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(6), and the reported neurologic dysfunction and bleeding could not be conclusively established through this evaluation.The patient remains ongoing on the heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(6), and the device is not available for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The hm3 lvas instructions for use (ifu) lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including other neurological events (not stroke-related) and bleeding, and provides information regarding anticoagulation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11055880
• MDR Text Key: 223168986
• Report Number: 2916596-2020-06075
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7614657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116