MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 APICAL CUFF; VENTRICULAR (ASSIST) BYPASS

Model Number	106522
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Related mfr number: 2916596-2020-05966.It was reported that during the (b)(6) 2020 thoracotomy implant, bleeding was observed from the interface between the pump inflow cannula and the apical sewing ring.Prior to the bleeding, the surgeon sutured the apical sewing ring to the left ventricular (lv) apex, then cored utilizing the coring knife; additional tissue was removed from the apex utilizing surgical tools.The surgeon used 4 pledged sutures and ran the sutures to adhere the sewing ring to the lv apex.Surgical adhesive was placed around the perimeter of the sewing ring.The pump was placed into the left ventricle and engaged; as evidenced by the yellow lines disappearing on the purple cuff lock.While performing the outflow graft anastomosis, bleeding was observed from the lv apex between the pump and the sewing ring.The surgeon added multiple pledged sutures; bleeding continued.The purple cuff lock was disengaged to try to re-seat the pump two times on the apical sewing ring; bleeding continued.The patient was put back on coronary bypass, and the heartmate 3 pump was removed from the lv apex to inspect the purple cuff lock prongs that engage with the sewing ring.The purple prongs appeared intact and not bent.A small amount of tissue debris was removed from pump groove, near the locking mechanism.The locking mechanism of the pump was tested using a mini apical sewing ring from the shelf; it fully engaged and locked appropriately.The surgeon added additional sutures outside the ventricle into the lv cavity, then back through the sewing ring to pull the tissue closer to the sewing ring.They proceeded to place the pump in the lv apex through the sewing ring, and the yellow lines disappeared again, demonstrating that the locking mechanism engaged.The bleeding continued, and surgical adhesive was placed around the sewing ring and pump.The pump was reseated a total of 3 times, and the yellow lines on the purple cuff lock disappeared each time.The surgeon attempted to increase the pump speed and take the patient off of coronary bypass.The bleeding slowed down as the pump speed was increased.The parameters were as follows: pump speed 5400 rpm, flow 4.5 liters per minute, pulsatility index 2.3, power 3.8 w.The thoracotomy incision was left open for the patient to leave the operating room to go to the intensive care unit.The hemi sternotomy incision was closed.Factor 7 protein (clotting factor) was administered.On (b)(6) 2020, the patient returned to the operating room for a washout.The bleeding had slowed down but some bleeding was still observed from the lv apex.The pump flows were between 4 liters per minute and 6 liters per minute.The patient was retained in the intensive care unit.The life-threatening bleeding event required multiple massive transfusions, with the patient receiving approximately 50 units of various blood products in the first 24 hours.The interface between the pump inflow cannula and the apical sewing ring was packed with hemostatic material, and the rest of the patient's chest was packed with lap sponges and trauma gauze.The bleeding ceased after approximately 48 hours of packing, and with anticoagulation/antiplatelet medications withheld.The patient was then slowly restarted on anticoagulation and antiplatelet medication.
Additional Manufacturer Narrative
Manufacturer investigation conclusion: a specific cause for the report of bleeding between the pump inflow cannula and the apical sewing ring during implant could not be determined through this evaluation.The patient remains ongoing on heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(6), with no further related issues at this time.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 lvas final assembly device history records showed that the cuff lock installed on (b)(6) passed all inspection and testing steps.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists bleeding as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 5 ¿surgical procedures¿ (under ¿preparing the ventricular apex site¿) contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left ventricle.This section cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 lvas.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 APICAL CUFF
• Common Device Name: 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: 11032973
• Report Number: 2916596-2020-05967
• Device Sequence Number: 19506102
• Product Code: DSQ
• UDI-Device Identifier: 00813024012825
• UDI-Public: 00813024012825
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 106522
• Device Lot Number: 7474815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 05/03/2022
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 12/31/2020; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEARTMATE 3 LVAS IMPLANT KIT.; HEARTMATE 3 LVAS IMPLANT KIT
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White