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

Model Number 106015

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

Patient Problems Bacterial Infection (1735); Hemolysis (1886); Skin Infection (4544); Lactate Dehydrogenase Increased (4567)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with known left ventricular assist device (lvad) infection was having elevated lactate dehydrogenase (ldh) levels and tea colored urine.The patient was on heparin and integrilin (eptifibatide) drips.The log files contained a few pulsatility index (pi) events and routine power source changes.Additional information was received that abdominal, pelvis, and thorax computed tomography (ct) results showed that there was no acute intra-abdominal pathologic process identified.Specifically, no evidence of suspicious intra-abdominal fluid collection, ascites, hemoperitoneum or retroperitoneal bleed was found; there was a minimally distended urinary bladder with mild scattered bowel gas; there were two cholelithiasis with innumerable punctate dependent cholelithiasis, no gallbladder distention or inflammatory changes, and there was an interval development small greater left pleural effusions with basilar compressive atelectasis.Peripheral blood cultures were done on (b)(6) 2022 was positive for enterococcus faecalis and it was being treated with ampicillin, penicillin, vancomycin, daptomycin, zyvox (linezolid).Cultures from another hospital also showed vancomycin susceptible enterococcus faecalis via polymerase chain reaction (pcr).Cultures done on (b)(6) 2022 were negative to date and the computed tomography (ct) of the abdomen and pelvis were without clear evidence suggestive of the left ventricular assist device (lvad) involvement.On (b)(6) 2022, abdominal ultrasonogram without evidence of vegetation along the driveline.Also, on (b)(6) 2022, a transesophageal echocardiogram (tee) showed no evidence of vegetations on valves or along visualized portions of implantable cardioverter defibrillator (icd) lead.A positron emission tomography - computed tomography (pet-ct) done on (b)(6) 2022 was suggestive of lvad infection.Cardio thoracic surgery (cts) was consulted regarding re-implant but the patient was too high of a surgical risk.The patient was to continue iv rocephin (ceftriaxone) 2 gram (gm) every 12 hrs and iv ampicillin 2 gm every 8hrs (dose adjusted for renal function) and both medications were planned for 8 weeks course after the negative blood cultures.Infectious diseases was consulted and recommended iv antibiotics through 18jul2022 and then to transition to amoxicillin 500mg twice a day in addition to oral doxycycline.

Manufacturer Narrative

The patient was previously admitted for infection in mfr# 2916596-2022-12218.Manufacturer's investigation conclusion: a direct cause for the patient¿s reported infection could not be conclusively determined through this evaluation.A direct relationship between the device and the reported hemolysis symptoms and pleural effusions could not be conclusively determined through this evaluation.The submitted log file contained data from (b)(6) 2022 to (b)(6) 2022.The pump operated above the low speed limit of 8600 rpm for the duration of the log file.There were no atypical alarms and the log file appeared to show the system operating as intended.The patient remains ongoing on ventricular assist device (vad) support with no further issues reported at this time.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate ii lvas instructions for use (ifu) is currently available.Infection and hemolysis are listed as adverse events that may be associated with the use of heartmate ii lvas.The patient care and management section of the ifu discusses anticoagulation, including recommended inr (international normalized ratio) values.Patient handbook is also available.Section 2 entitled ¿how your heart pump works¿ and section 4 entitled ¿living with the heartmate ii¿ outline care instructions in reference to preventing infection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) 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: 14999836
• MDR Text Key: 295778427
• Report Number: 2916596-2022-12222
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG