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

Model Number 106524US

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

Patient Problems Pleural Effusion (2010); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Gastrointestinal Hemorrhage (4476)

Event Date 05/02/2022

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 complained of abdominal pain on (b)(6) 2022.Computed tomography (ct) scan diagnosed a small bowel obstruction at entero-entero anastomosis, concerning for ileus.No treatment was administered.During the ct scan, there was an incidental finding for suspected aortic valvular vegetation.Coumadin was held in preparation for gastrointestinal surgery.The patient underwent laparoscopic lysis of adhesions on (b)(6) 2022 at the entero-entero anastomosis site.Transthoracic echocardiography (tte) on (b)(6) 2022 revealed that the valve vegetation was a possible thrombus in aortic valve.The patient experienced pericardial and pleural effusion.Laparoscopy showed melena and bloody nasogastric tube output requiring 6 units of blood to be transfused.Esophagogastroduodenoscopy (egd) on (b)(6) 2022 showed oozing from anastomosis site and that required 2 clips and epinephrine injection.The patient received 1 unit of red blood cells on (b)(6) 2022.

Manufacturer Narrative

Section a: date of birth should have been redacted from the initial report for clinical study patient manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (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.Review of the sterilization and packaging documentation showed no deviation from manufacturing specifications.The implant kit was shipped on (b)(6) 2022.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists adverse events such as infection (local, driveline, and pump pocket), bleeding, and arterial non-central nervous system (cns) thromboembolism as adverse events that may be associated with the use of the heartmate 3 lvas.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.Section 5 of the ifu, ¿surgical procedures¿, warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.If not addressed, the lvad will not be able to provide the intended flow.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the transesophageal echocardiogram (tee) and computed tomography (ct) scans revealed that both ventricles had severely impaired global function and although thrombus was not present in either, hypertrophy was present in the left ventricle.The patient also experienced mild mitral valve and tricuspid valve regurgitation that were pre-existing and trace pulmonary valve regurgitation.Ct scan also showed an incidental finding of a hyperenhancing lesion in the posterior right hepatic lobe.On (b)(6) 2022, the patient had an intraabdominal postsurgical infection of e.Coli.The patient was put on antibiotics to treat the infection from (b)(6) 2022 through (b)(6) 2022.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14565039
• MDR Text Key: 293078122
• Report Number: 2916596-2022-11016
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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: 01/25/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8404794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG