MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 104911

Device Problems Break (1069); Device Stops Intermittently (1599); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 5 years, 2 months.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that, on (b)(6) 2016, the patient presented to the clinic due to the occurrence of pump stops while supported by batteries.X-rays of the percutaneous lead and the patient's system controller log files were submitted to the manufacturer's technical services for review.The submitted x-rays and log file was reviewed by a representative of the manufacturer's technical services team.The x-rays of the percutaneous lead were found to display a couple suspect areas both on the internal and external portions of the percutaneous lead.The log file contained approximately 56 days of data and revealed the occurrence of 10 pump stops and 4 low speed advisories.These began on (b)(6) 2016 and the last recorded was on (b)(6) 2016.This type of behavior had been previously linked to potential issues with the percutaneous lead.On (b)(6) 2016, the patient was reported to be doing well and the patient was asymptomatic.A pump exchange was planned for (b)(6) 2016.On (b)(6) 2016, the pump exchange was completed.Reportedly, the exchange went well, with no complications.At the time of the exchange, it was noted that the bend relief of the pump being removed was disconnected upon reentry into the chest.It did not appear to be compressing the graft or rubbing against it.The patient was implanted prior to the implementation of the collar.A collar was placed at the time of the new pump being implanted.

Manufacturer Narrative

The pump was returned with the percutaneous lead (lead) cut approximately 9 inches from the pump housing and the remainder of the lead was returned in a 29 inch segment.Electrical continuity testing of both lead segments found all wires were electrically intact.Examination of the 29 inch lead segment found breakdown of the braided shield along the length of the lead; however, no area of compromised wire insulation was identified.Examination of the 9 inch lead segment revealed breakdown of the braided shield approximately 2.5 to 3 inches and 6 to 9 inches from the pump housing.Examination of the underlying wires revealed breaches in the red and black wires approximately 2.5 inches from the pump housing and breaches in the yellow, orange, and red wires approximately 6 to 6.5 inches from the pump housing.The observed wire damage appeared to be the result of fatigue due to abrasion against the braided shield.The system operates on a three phase motor; the yellow and green wires represent phase one, the black and brown wires represent phase two, and the red and orange wires represent phase three.If any of the exposed conductors contacted the braided shield while the patient was operating on a tethered power source, such as the power module, the resulting short to ground could have caused the low speed alarms and pump stoppage events.The reported event also could have been caused by a phase to phase short, which would occur if the exposed conductors of any two wires from different phases contacted each other or simultaneously contacted the braided shield while the patient was operating on tethered or battery power.Additionally, it was reported that the sealed outflow graft bend relief was disconnected during the pump exchange procedure; however, the event could not be confirmed as no photographs or images were submitted and the sealed outflow graft and sealed outflow graft bend relief are not available for evaluation.A review of the device history records showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its file on this event.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564071
• MDR Report Key: 6000205
• MDR Text Key: 56484929
• Report Number: 2916596-2016-01940
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

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: Lay User/Patient
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 83