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

Model Number 106016

Device Problems Mechanical Problem (1384); Failure to Align (2522)

Patient Problem Dyspnea (1816)

Event Date 05/26/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the patient underwent pump exchange from heartmate ii to heartmate 3 due to suspected driveline issues and inflow cannula malposition.The patient had a limitation of flow at the distal part of the outflow graft close to the aortic suture, which developed over time.Transesophageal echocardiogram (tee) was frequently done.The inflow cannula position orientation towards the myocardial anterior wall changed over time.Both issues were addressed for surgical corrections due to slow change of the patient condition, and the patient was monitored over the last few weeks due to a higher possibility of suction events and potential driveline issues.The patient had increased dyspnea and limited physical activity.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer' s investigation conclusion: the evaluation of heartmate ii left ventricular assist system (lvas), serial number: (b)(6), confirmed driveline wire damage.Also, the report of malposition of the inflow was confirmed.The pump, (b)(6), was returned assembled with the driveline severed approximately 1 inch from the pump header.The midsection and the distal portion of the driveline were returned with the pump.The sealed inflow conduit (the inlet tube, inflow conduit flex section, and inlet elbow) was returned attached to the pump inlet port.The outlet elbow was returned attached to the outlet port.The sealed outflow graft was returned unattached from the outlet elbow, and the outflow graft bend relief was not returned with the device.Upon disassembly of the (b)(6), visual inspection of the blood contacting surfaces within the pump revealed no evidence of any adhered or developed depositions or thrombus formations.The pump was cleaned, and the bearings, rotor and blood contacting surfaces were examined under a microscope; no anomalies were observed that would have contributed to a functional issue.Electrical continuity testing of the returned portions of the driveline was conducted, and all wires were found to be electrically intact.No wire-to-wire or wire-to-shield electrical shorts were induced during this test, despite manipulation of the driveline.Upon removal of the silicone jacket, the bionate layer of the distal portion of the driveline had a black discoloration from 2-16.5 inches and from 24-25 inches from the metal connector.The metal braided shield showed more severe breakdown at 4-5.5 inches on the midsection of the driveline, and from 2-6 inches and 12-16 inches from the controller connector on the distal portion of the driveline.Minor metal shield breakdown could be seen at approximately 7-10.5 inches from the metal connector on the distal portion of the driveline.Microscopic and visual inspection of the wires revealed insulation breaches in the mid section of driveline at 6, 6.5, and 9 inches of the orange wire, 9 inches of the brown wire, and 9 inches at the red wire.The driveline was then submerged in a saline bath for high potential testing to verify the integrity of each wire¿s insulation.The test revealed a breach at approximately 9 inches on the yellow wire of the midsection portion of the driveline and at approximately 2 inches on the green wire from the controller connector on the distal end of the driveline.All other wires did not reveal any areas of current leakage in the insulation.If the exposed conductors of the orange, brown, red, yellow, and green wires contacted the braided shield while the system was operating on a tethered power source such as the power module or mobile power unit (mpu), the resulting short to ground could have resulted in low speed and pump stop events.These events could have also occurred if the exposed conductors of these wires contacted the braided shield simultaneously or if the exposed conductors from two wires of different phases contacted each other while the patient was connected to battery power.The account also submitted a scan showing the malposition of the inflow cannula.The reported concern for pump malposition can be confirmed through these scans.During the investigation there were incidental findings.Visual inspection of the driveline potting inside the pump outlet housing (interior of the cable boss) noted that the potting had an opaque, yellow color with no evidence of fluid ingress into the surrounding space.The issue appeared to only be cosmetic, and the cause could not be conclusively determined.The pin in the motor capsule had a black discoloration.The distal portion of the driveline was returned with tape applied from 2- 17.5 inches from the controller connector due to a missing portion of the outer jacket.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.Section 5 of the ifu, ¿surgical procedures¿ outlines considerations for pump placement and orientation and also provides instructions regarding the preparation, installation, and orientation of the sealed inflow conduit.Section 5 (under ¿inserting the sealed inflow conduit¿) states to ¿select the optimal sealed inflow conduit orientation at the ventricular apex.The following is critical in determining orientation: the opening of the sealed inflow conduit should be directed toward the mitral valve and away from the intraventricular septum.Care must be taken to avoid excessive angulation of the sealed inflow conduit once the left ventricular assist device is in-situ.The ideal orientation will anticipate that the dilated lv may shrink in size as its workload is assumed by the pump.¿ sections 6 and 8 of the hmii ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.Additionally, these sections outline indications of driveline damage as well as the how to respond to such events.Furthermore, section 7 of the hmii ifu and section 5 of the hmii patient handbook address all hazard and advisory alarms, as well as how to respond to each alarm condition.The patient handbook also contains a section on handling emergencies and further instructs the user to call their hospital contact if the patient thinks that, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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: 14688515
• MDR Text Key: 294594900
• Report Number: 2916596-2022-11316
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 69 KG