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

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.

• 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 Key: 11181116
• MDR Text Key: 228202230
• Report Number: 2916596-2021-00214
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• 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 Date: 08/31/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 72