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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)
Event Date 02/15/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient was admitted for a gi bleed angioectasias.The patient presented to the er complaining of bright rend blood per rectum.In the ed the patient's map was 80, the patient was non-tachycardic, with an oxygen saturation of 96 at room air, there were no alarms upon lvad interrogation.The patients hemoglobin/hematocrit was 10.5/1.75 bun (blood urea nitrogen)/cr(creatinine) was 18/1/75, inr(international normalized ratio) was 2.1, fecal occult blood test was positive.The patient was deemed to be admitted for further evaluation and management.The patient received bid(twice a day) ivppi (intravenous proton-pump inhibitors) and was made npo (nothing by mouth) on admission.Hgb (hemoglobin) was stable at 9.Warfarin was held and the patient received a bowel prep.The patient underwent an egd (esophagogastroduodenoscopy) and colonoscopy on (b)(6) 2019.The colonoscopy revealed a sessile polyp with in the gastric antrum with both active bleeding and stigmata of previous bleeding.The polyp was clipped and cauterized.The colonoscopy demonstrated internal hemorrhoids.It was recommended a minimum of 12 weeks bid (twice a day) ppi (proton pump inhibitors) for ugib(upper gastrointestinal bleed) , docusate otc (over the counter) bid(twice a day) for hemorrhoids, and close gi(gastrointestinal) follow up.The patient's stool normalized and their hemoglobin remained stable.The stop date was listed as (b)(6) 2019.No additional information was provided.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of gastrointestinal (gi) bleeding could not be conclusively determined.Bleeding 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.Gi bleeding has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key11181116
MDR Text Key228202230
Report Number2916596-2021-00214
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
Combination Product (y/n)N
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 01/19/2021
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 Date08/31/2018
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/13/2021
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received01/15/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
Patient Weight72
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