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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION THORATEC HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problems Obstruction of Flow (2423); Protective Measures Problem (3015)
Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194)
Event Date 09/08/2021
Event Type  malfunction  
Event Description
Senior male patient with a history of end-stage non-ischemic cardiomyopathy status post heartmate 3 lvad implant about three years ago, along with asd (atrial septal defect) closure, right femoral artery and iliac thrombectomy with patch repair, and removal of thrombus on ra lead.He was recently admitted for recurrent low-flow alarms on his lvad, found to have outflow graft obstruction and severe ai, s/p surgical revision of his outflow graft followed by tavr (transcatheter aortic valve replacement) in (b)(6) 2021 with excellent clinical result who presented on (b)(6) with black stools, lightheadedness and significant hgb drop consistent with gi bleed.The patient recently presented to the ed with spots of bright red blood after straining to have a bowel movement, found to have a stable hgb, and discharged home.Bleeding was felt not to be related to vad.He then reported about a week of black stools.An inr (international normalized ratio) performed at admission revealed the patient was supertherapeutic on warfarin.He had a colonoscopy which showed blood from the terminal ileum.A cta (computed tomography angiography) abdomen/pelvis obtained which showed a blush of contrast in the appendix seen on arterial phase with pooling of contrast seen on delayed phase imaging in the cecum and appendix consistent with active contrast extravasation.This is likely arising from ileocolic branch of superior mesenteric artery.The patient received two units of blood for a hct of 20.
 
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Brand Name
THORATEC HEARTMATE 3 LVAS IMPLANT KIT
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key12487448
MDR Text Key271890030
Report Number12487448
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number106524US
Device Catalogue Number106524US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2021
Device Age3 YR
Event Location Home
Date Report to Manufacturer09/17/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age21170 DA
Patient Weight70
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