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

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.

Manufacturer Narrative

The device was not returned for evaluation.There was no reported device malfunction.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information provided, the reported death was unrelated to the device, however, the procedure may have contributed to the cascade of events due to the atrial septal defect caused by steerable guide catheter, which is related to procedural circumstances.It should be noted that the atrial septal defect (asd/atrial perforation), death, respiratory distress/failure, cardiac arrest, heart failure, ventricular fibrillation, cerebrovascular accident, ischemia, hypertension and shock are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10488204
• MDR Text Key: 205498034
• Report Number: 2024168-2020-07338
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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: 08/22/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90823U145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS; 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Death
• Patient Age: 92 YR
• Patient Weight: 60