MAUDE Adverse Event Report: ABBOTT LABORATORIES/THORATEC CORP. HEARTMATE II LVAD; VENTRICULAR (ASSIST) BYPASS

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 07/10/2020

Event Type  Injury  

Event Description

Patient seen in vad clinic on (b)(6) 2020.Interrogation of the heartmate ii controller revealed a recurrent driveline fault alarm.Log files were downloaded and sent to abbott labs for evaluation.Log files captured periods of driveline fault events throughout the log without any low speed or pump stop events noted.Controller was changed per abbott recommendations which did not alleviate these alarms.Abbott engineers planning to splice the driveline, due to the potential the patient may require a pump exchange, the patient was brought in the day prior to assess hemodynamics of a pump explant as ef was 55-60%.Patient admitted on (b)(6) 2020 for rhc/cpet/echo which showed a marked increase in pa pressures that argue against stability to explant the hm ii lvad.Abbott engineers spliced the driveline on (b)(6) 2020 however they noted the driveline fault was due to an internal driveline fracture.The patient was taken to the or on (b)(6) 2020 for a lvad pump exchange.The hm ii pump was explanted and a hm 3 pump implanted.The hm ii pump and driveline were sent to abbott labs for evaluation.Surgery went well.The patient recovered and was discharged to home on (b)(6) 2020.The only relevant data was the log files sent to abbott labs for evaluation results noted above.Fda safety report id #: (b)(4).

• Brand Name: HEARTMATE II LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES/THORATEC CORP.
• MDR Report Key: 10326351
• MDR Text Key: 200681937
• Report Number: MW5095730
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 67