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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS; VENTRICULAR (ASSIST) BYPASS
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THORATEC CORPORATION HEARTMATE 3 LVAS; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)
Patient Problems Abscess (1690); Bacterial Infection (1735); Erythema (1840); Organ Dehiscence (2502)
Event Date 01/29/2019
Event Type  Injury  
Event Description
A heartmate 3 was implanted in a patient.A few weeks later, the pt required reoperation due to sternal dehiscence at the sternomanubrial joint requiring a sternal plate; operating room cultures were negative.Pt was discharged home, and presented a month later with pronounced erythema over the mediastinal incision; chest ct revealed loose screw tip protruding into the mediastinum.A month later, the pt underwent his second sternal debridement and was found to have deteriorated bone with abscesses; operating room cultures grew staph epidermidis and staph warneri.A third sternal debridement was performed a few weeks later in preparation for future pectoralis flap.Fourth sternal debridement was conducted on the next week to excise dead bone.Closure of the wound occurred a few weeks later via right pectoral flap, left pectoralis major myocutaneous flap, primary closure and incisional vacuum-assisted closure (vac) placement.
 
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Brand Name
HEARTMATE 3 LVAS
Type of Device
VENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
4550 norris canyon rd
san ramon CA 94583
MDR Report Key8878464
MDR Text Key153815299
Report Number8878464
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 Nurse
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Device Age2 MO
Event Location Home
Date Report to Manufacturer08/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age23725 DA
Patient Weight99
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