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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Cardiac Enzyme Elevation (1838); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Respiratory Distress (2045); Shock (2072); Tachycardia (2095); Vasoconstriction (2126); Ventricular Fibrillation (2130); Heart Failure (2206); Coma (2417); Respiratory Failure (2484); Atrial Perforation (2511)
Event Date 08/10/2020
Event Type  Death  
Manufacturer Narrative
The device was indicated as not returning for analysis. The investigation is not yet complete. A follow-up report will be submitted, providing additional, relevant information.
 
Event Description
Patient (b)(6). This report is filed as an enlarged atrial septal defect occurred following the mitraclip procedure. The cascading adverse events include death. It was reported that on (b)(6) 2020, a mitraclip procedure was performed for mitral regurgitation (mr) grade 4. Two mitraclips were successfully implanted, reducing the mr to grade 2, without a device issue. On (b)(6) 2020, after defecatio, the patient had sudden cardiac arrest. The patient was found unconscious, without spontaneous breathing. Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated. Per physician, the cardiac arrest was less likely due to drug interaction. The cardiac arrest was hypothesized to be due to takotsubo syndrome with consequent ventricular tachycardia/ventricular fibrillation and most likely due to a decrease of preload and drop of arterial pressure after defecation resulted in acute right ventricular failure and right-left shunt via atrial septal defect (asd). The event resulted in severe neurological complications, an ischemic stroke with left-side hemiparesis, and leaving the patient in a coma. Medications had been provided as treatment. On (b)(6) 2020 per imaging, the ischemic stroke was verified within 2 zones of the right hemisphere. An echocardiogram displayed takotsubo syndrome. Per imaging, a new akinetic zone was observed, along with slightly elevated cardiac lab, troponin. There was no coronary occlusion. The patient remained unconscious and intubated. That same day, on (b)(6) 2020, severe oxygen desaturation, severe respiratory failure, along with severe arterial hypoxemia (sao2 to 40%) and right ventricular failure occurred. Reportedly, this was due to a massive right to left shunt via an asd. There was a reversal of pulmonary hypertension to the base-line level (90-100mmhg) due to hypoxic vasoconstriction. Severe congestion in the viscera along with pulmonary hypovolemia was observed. Medications were provided and cpr was performed. Acute right ventricular failure occurred, which led to death that same day. The mitraclips remained stable and well seated on the leaflets. Per physician, the events were unrelated to the implanted mitraclips. There was no device malfunction reported. No additional information was provided regarding this issue.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10488204
MDR Text Key205498034
Report Number2024168-2020-07338
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/22/2020
Device Catalogue NumberSGC0302
Device Lot Number90823U145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
Treatment
2 IMPLANTED MITRACLIPS
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