MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

The ct scans, site investigators and neurologists confirmed that the neurological event experienced by the patient was a hemorrhagic conversion of the pre-implant ischemic stroke.Their conclusion is supported by the location of the hemorrhagic stroke which is in the same area of the brain as the pre-implant ischemic stroke.An ischemic stroke weakens the vasculature and predisposes the patient to a subsequent bleed because of the compromised tissue integrity.Additionally, the patient's condition was impacted by a low platelet count that was present pre-implant that persisted in the post-implant period (thrombocytopenia).The anticoagulation required because of the presence of the tah-t also increased the patient's risk for the hemorrhagic conversion of the stroke.The dramatic change in the patient's condition resulting from the hemorrhagic conversion of the pre-implant stroke was not a device-related event.The event was a result of the patient's pre-implant stroke and co-morbidities that were impacted by the administration of anticoagulants that were required because of the presence of the tah-t.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient, a syncardia 70 cc tah-t destination therapy study subject, experienced a change in mental status.A head ct revealed a 3.2 x 2.5 x 2.9 cm hemorrhage totaling 12 ml in volume in the same location as the cva experienced pre-implant on (b)(6) 2018.The site investigators determined that the current cranial bleed is a hemorrhagic conversion of the pre-implant ischemic cva in the same location.The hemorrhagic conversion of the pre-implant ischemic stroke dramatically changed the patient's neurological status.The patient required mechanical ventilation following the event.The modified rankin scale (mrs) assessment revealed a functional classification of 5 which is indicative of severe disability, and a bedridden state requiring constant nursing care.The national institute of health stroke scale assessment revealed a score of 25 which is indicative of a severe stroke.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7659973
• MDR Text Key: 113069107
• Report Number: 3003761017-2018-00237
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 110953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR