MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

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

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tachycardia (2095); Respiratory Failure (2484); Thromboembolism (2654); Renal Impairment (4499); Skin Infection (4544)

Event Date 06/15/2021

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 was admitted 15jun with acute blood loss anemia after left ventricular assist device (lvad) surgery.The patient was transfused with 4 units of packed red blood cells, 3 units of platelets, 1 unit of fresh frozen plasma, 10 units of cryoprecipitate.There were almost 2 liters of chest tube output in first 2 hours of arrival.During chest exploration at bedside, the patient was given 5 units blood, 2 units of fresh frozen plasma, and 1000cc of albumin.Chest was left open and the patient was taken back to operating room on 17jun for chest closure.On 16jun, the patient had elevated creatinine pre-procedure with a 4.97 peak on 09jun.It improved to 2.15 on the day of surgery.Concerning for renal dysfunction/oliguria.The patient also went into atrial fibrillation after surgery (had prior history of atrial fibrillation).The patient was given amiodarone bolus and started on amiodarone drip.On 21jun, the patient was noted to have abdominal pain and distension.Computed tomography (ct) showed cecal volvulus concerning for bowel ischemia.The patient was taken to operating room and found hemorrhagic ascites and cecal volvulus with distended cecum with areas of necrosis noted.Ileocecostomy with end ileostomy performed.Post-operative course required 8 units of red blood cells as the patient was hemodynamically unstable.Hematoma was found in abdomen.On 23jun the patient had 500ml drainage from abdomen before it was packed.The patient returned 25jun and had 1100ml of old blood evacuated.Venous bleeding in the retroperitoneal was controlled and the wound was closed.The patient was extubated on 20jun and then reintubated 21jun for operating procedure.On 27jun the patient had endotracheal tube (ett) exchange for cuff leak, white out of left lung.Bronchoscopy was performed likely secondary to mucous plug.Chest x-ray showed improvement the following day.Thoracic surgery was consulted for trach placement.Related manufacturer report number # 3003306248-2021-02987.

Event Description

It was reported that instead of atrial fibrillation, the patient actually went into ventricular tachycardia post-operative (had history of ventricular tachycardia).He was given amiodarone bolus and drip.On (b)(6) 2021, the patient had a neurological dysfunction event.Head computed tomography (ct) showed subacute left anterior cerebral artery territory infarct.There was no acute intracranial hemorrhage or midline shift.The patient was reintubated on (b)(6) for exploratory laparotomy.The patient was transfused a total of 28 units of red blood cells from (b)(6) to (b)(6) for bleeding.The patient had leukocytosis on (b)(6) but blood cultures were negative.The patient was started on empiric antibiotics.Tracheostomy was performed on (b)(6) for respiratory failure.There was also a sudden drop in right ventricular assist device (rvad) flows, extracorporeal membrane oxygenation (ecmo) circuit exchanged on (b)(6) 2021.On (b)(6) the patient developed drainage from abdominal wound, emesis, fever, and tachycardia.Cultures remained negative but additional antibiotics were given.Repeat head ct on (b)(6) showed evolving left anterior cerebral artery infarct with no acute hemorrhage or midline shift.Ct scan on (b)(6) also showed small renal and splenic peripheral infarcts.Heparin drip was restarted.Tracheal aspirate culture on (b)(6) grew gram-positive cocci but final result was normal for upper respiratory flora.The patient had ct scans on (b)(6) and there was no active concern for infection.Discontinuation of antibiotics was recommended.On (b)(6) 2021 the patient developed persistent metabolic acidosis after creatinine and urine output improved, requiring sustained low-efficiency dialysis (sled).On (b)(6) ct scan found a developing left occipital infarction.Warfarin was restarted.No new changes on (b)(6) ct.Related manufacturer report # 3003306248-2021-02987 & 3003306248-2021-03000.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to the heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not conclusively be determined through this evaluation.Per additional information from the ventricular assist device (vad) coordinator, the patient was discharged and no longer remains ongoing on ecmo/rvad support.No product will be returned.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit was shipped on 17may2021.The heartmate 3 lvas instructions for use (ifu) and patient handbook are currently available.Section 1, ¿introduction¿, lists cardiac arrhythmia, bleeding, stroke, multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, right heart failure, and heart failure), non-central nervous system (cns) thromboembolism, infection and driveline infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿ also provides information regarding anticoagulation, including the recommended inr values.Additionally, this section also lists arrhythmia, thromboembolism, infection, and neurological dysfunction as potential late postimplant complication.Care instructions regarding preventing infection are provided in various sections of the ifu and patient handbook, including caring for the driveline exit site and controlling infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Post-op day one (b)(6) 2021 the patient was noted to have urine output less than 0.3 milliliters/kilogram/hour and needed intravenous fluid resuscitation for oliguria.On (b)(6) 2021 the patient was transfused an additional one unit of red blood cells.Tracheostomy was downsized on (b)(6) 2021 and capped on (b)(6) 2021.The patient removed their tracheostomy but it was then kept out since the patient was stable.On (b)(6) 2021 the patient developed drainage and redness for the left ventricular assist device (lvad) driveline site.Computed tomography (ct) scan showed thickening but no stranding or abscess.Culture grew pseudomonas.Infectious disease recommended four weeks of cefepime and follow-up in clinic.The patient was weaned off sustained low-efficiency dialysis (sled) and creatinine returned to normal by the time the patient was discharged.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12102844
• MDR Text Key: 259593277
• Report Number: 2916596-2021-03506
• 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
• Report Date: 09/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7911583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70