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

Model Number 106015

Device Problems Electrical Shorting (2926); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Short-to-shield on (b)(6) 2018 is recorded under mfr #2916596-2018-02051.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Patient with known short to shield on (b)(6) 2018.Underwent elective pump exchange.Pump exchange for short to shield.No further information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of heartmate ii lvas identified an internal driveline issue that could have contributed to the reported short to shield.It was reported that the patient underwent a pump exchange on (b)(6) 2019.(b)(6) was returned assembled with the driveline severed approximately 7¿ from the pump housing.The remainder of the driveline was returned in a segment measuring approximately 31¿.Metal braided shield breakdown was observed adjacent to the metal connector through approximately 7¿ from the metal connector.Minor breakdown was also observed along the remainder of the driveline.Upon removal of the metal braided shield, visual inspection of the underlying wires revealed a breach in the orange wire approximately 12¿ from the pump housing, exposing the inner conductors.This damage appears consistent with fatigue failure due to repetitive flexing and abrasion against the metal braided shield.If the exposed inner conductors of the orange wire made direct contact with the metal braided shield while the system controller was connected to a tethered power source such as the power module or the mpu, the resulting electrical short to ground could have resulted in pump stops or low speed events.Incidental finding: evaluation of the returned device revealed a tear in the outer silicone jacket approximately 2.5" from the metal connector.The underlying bionate layer appeared unremarkable.The heartmate ii lvas patient handbook, a section on ¿caring for the driveline¿; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.Section 5 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, as well as how to respond to each alarm condition.Heartmate ii lvas ifu, section 6 entitled ¿patient care and management¿ outline indications of driveline damage as well as how to respond to such events.Section 7 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9262257
• MDR Text Key: 164500488
• Report Number: 2916596-2019-04909
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 107