MAUDE Adverse Event Report: THORATEC CORPORATION ASSY, CABLE, PM, PATIENT, 14V; LEFT VENTRICULAR ASSIST SYSTEM

Model Number	105903
Medical Device Problem Codes	Naturally Worn (2988); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate age of device ¿ 6 years 5 months (the age is calculated from the date of implant to the event date).The patient remains on lvad support with no further issues reported.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013.It was reported the patient was seen for a follow visit and noted to have twisting of driveline (dl) with multiple portions covered with rescue tape.Interrogated due to concern of integrity of wires inside driveline.On interrogation of device, patient had no external power alarm on (b)(6) that occurred when switching white lead on patient cable.The log file was reviewed.The log file analysis showed the no external power on (b)(6) 2019 while the patient was switching power sources.The dl data appeared normal so the twisting had not degraded the conductors at this time.There were no other unusual events recorded in the log file.The mcs equipment was operating as intended.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of cosmetic damage to the driveline could not be confirmed as there was no product returned for analysis and no photos were submitted for evaluation.Additionally, the submitted log files contained no unusual events indicating an issue with the driveline.No atypical alarms were captured and the pump operated above the low speed limit for the duration of the log file.The log file appeared to show the system operating as intended.The patient remains ongoing on vad support.The hm ii lvas ifu contains information on caring for the driveline and addresses damage due to wear and fatigue of the driveline.The hmii lvas ifu explains that pump flow is estimated from the pump power and notes that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: ASSY, CABLE, PM, PATIENT, 14V
• Common Device Name: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8735884
• Report Number: 2916596-2019-02891
• Device Sequence Number: 2091923
• Product Code: DSQ
• UDI-Device Identifier: 00813024011217
• UDI-Public: 00813024011217
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2019

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 Expiration Date: 08/31/2015
• Device Model Number: 105903
• Device Catalogue Number: 106762
• Device Lot Number: 1101609280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 09/13/2019; 09/19/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/11/2019; 09/18/2019; 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 73