MAUDE Adverse Event Report: THORATEC CORPORATION HMII SEALED OUTFLOW GRAFT

Catalog Number 103393

Device Problem Partial Blockage (1065)

Patient Problems Dyspnea (1816); Fatigue (1849); Thrombus (2101)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # (device identifier): (b)(4).Approximate age of device ¿ 2 years and 3 months.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) on (b)(6) 2015.It was reported that the patient was admitted on (b)(6) 2017 for respiratory symptoms and frequent low flows.The patient presented with cough, dyspnea, fatigue, and poor appetite.Labs were at baseline at time of admission.Probnp became elevated during hospital course.The submitted log file was reviewed by a representative of the manufacturer's technical services team and revealed 238 low flow hazard alarms over an approximate 1 day period.The lvad clinician requested if log file showed suspect thrombus.The technical services representative responded that the data that was reviewed showed no indication of thrombus being present within the motor chamber; however that did not mean that thrombus was not present in the circulatory loop.A ramp study completed on (b)(6) 2017 found left ventricle (lv) dimensions did not change with speed increase up to 10,200 rpm.Additionally, aortic valve excursion also did not change.Cta on (b)(6) 2017 showed outflow graft thrombus.The patient was treated with gentle fluid resuscitation initially in an attempt to improve pre-load.On (b)(6) 2017 the patient¿s obstructed outflow graft (ofg) was replaced with a new ofg.

Manufacturer Narrative

The report of frequent low flow alarms was confirmed through the evaluation of the submitted system controller log file.No ct scan images or photos of the explanted sealed outflow graft (lot # 352602) were provided by the customer and the explanted outflow graft was reportedly disposed; therefore, the report of outflow graft thrombus could not be confirmed and a specific cause for the low flow events could not be conclusively determined through this evaluation.The submitted log file contained data from 07oct2017 14:08 ¿ 08oct2017 21:38 and was almost entirely occupied by low flow hazard alarms while the pump was operating at the fixed speed of 9000 rpm.All low flow alarms were recorded when the estimated flow was calculated at 2.4 lpm, which correlated with low pump power values of 3.9-4 watts.Despite the low flow alarms, the pump speed remained above the low speed limit for the duration of the log file.The patient remains ongoing on vad support with the new outflow graft with no additional events reported at this time.Thrombus is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HMII SEALED OUTFLOW GRAFT
• Type of Device: SEALED OUTFLOW GRAFT
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7001433
• MDR Text Key: 91061268
• Report Number: 2916596-2017-02607
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 103393
• Device Lot Number: 352602
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 62