MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Model Number SGC0701

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Tachycardia (2095); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 05/04/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a death.It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr).The patient presented with a small heart, maximum height possible for trans-septal puncture 3.4cm, restricted posterior leaflet, opposing anterior leaflet flail, large coaptation gap 8mm.During the procedure, the ntw clip got entangled in chordae.In an attempt to free the clip, papillary muscle was ruptured.The patient experienced cardiac tamponade and pericardial effusion, requiring emergency pericardiocentesis.The patient developed complete heart block, ventricular tachycardia (vt) and ventricular fibrillation (vf), requiring defibrillation and cardiopulmonary resuscitation (cpr).Xtw clip was implanted lateral a2/p2.Another clip (ntw) was implanted a1/p1.Mr was reduced to grade 2.On (b)(6) 2023, the patient experienced multi organ failure, primarily liver and kidney.The patient developed acute renal failure and disseminating intravascular coagulation (dic) post-operation.Pupils were found to be blown and the family asked for withdrawal of treatment.Subsequently, the patient expired.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

Based on the available information, the cause of the reported cardiac arrest, cardiac tamponade, pericardial effusion, ventricular tachycardia (vt) and ventricular fibrillation (vf) appears to be cascading effect of the reported tissue injury.The cause of the reported hemorrhage appears to be due to procedural conditions.The cause of the reported death appears to be due to the procedural conditions.The reported effect of cardiac arrest, cardiac tamponade, pericardial effusion, ventricular tachycardia (vt), ventricular fibrillation (vf) and death are listed in the instructions for use (ifu), and are known possible complications associated with mitraclip procedures.The reported medical interventions were the results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.This event was further reviewed by an abbott vascular medical affairs director.The reviewer stated that ¿the patient is (b)(6) years old and had an acute mi and rca stent placed on (b)(6), 2023.Due to severe mr-not clear if this was due to mi or preceded it.The patient¿s papillary muscle rupture could have been due to manipulation of the clip against recently infarcted tissue; moreover, the injury could have been transmural causing lv perforation and subsequent tamponade and cardiac arrest.In the absence of imaging, an adequate root cause analysis cannot be performed.There does not appear to be a primary failure of the device; however, entrapment of the device and attempts to free the clip likely caused the aforementioned injury.The papillary muscle rupture, myocardial perforation, tamponade, cardiac arrest and vt/vt was likely initiated by the aforementioned injury in a patient with infarcted tissue.Patient eventually died as a result of the events which led to multiorgan failure and dic.".

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16993908
• MDR Text Key: 315859658
• Report Number: 2135147-2023-02290
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21221R1071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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): Death
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 40 KG