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

Model Number SGC0701

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

Patient Problems Hypoxia (1918); Perforation (2001); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/21/2022

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 hypoxia, atrial perforation requiring intervention and death.It was reported that on (b)(6) 2022 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+, with a dilated left atrium.The patient presented with a pre-existing pleural effusion and in sick condition.One mitraclip was implanted successfully, reducing the mr to grade 1+.Approximately 30 minutes post-procedure, the patient became hypoxic with oxygen saturation at 77%.Further inspection revealed an atrial septal defect (asd) with right to left shunting and worsening right heart failure due to the shunting.The asd was successfully closed using a vascular plug, and the patient stabilized.A few hours later, the patient's pre-existing pleural effusion was treated with a chest tube.After chest tube insertion, bleeding from the chest tube was noted and the patients blood pressure dropped.The patient expired.There was no cardiac effusion noted.Reportedly, the only procedure issue was the previous left atrial to right atrial shunting, with a drop in oxygen saturation that the patient did not recover from, although the asd had been successfully closed.Per physician, the cause of death is unclear, however, the physician does not believe the clip was the cause.Reportedly, the patient was in sick condition.The patient was unable to recover from the drop in blood pressure noted after chest tube insertion, and was unable to fully recover from the drop in oxygen saturation from the previous shunt.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported heart failure was due to procedural conditions (repair of the heart).The cause of the reported perforation and death could not be determined.The reported hypoxia is a cascading effect of the reported perforation.The reported perforation, heart failure, and death are listed in the mitraclip system instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Additionally, this event was further reviewed by the abbott medical affairs team, and the reviewer stated that ¿the patient underwent a mitraclip procedure for severe, grade 4 functional mr on (b)(6), 2022.The patient had a single mitraclip nt implanted.Post-implant mr was reduced to grade 1.Shortly after the procedure, the patient developed hypoxia with oxygen saturations of 77%.An echo showed a stable mitraclip and no pericardial effusion.There was a large atrial septal tear (ast) the quantification of which is not provided.This was treated with a closure device (model of closure device not provided).The following day, while undergoing a chest tube placement for a pre-existing pleural effusion, the patient ¿coded¿ and resuscitative efforts were not successful, and the patient died on (b)(6), 2022.By echo, the mitraclip was stable with no pericardial effusion.Please note that details of the ¿code¿ are not provided such as the first rhythm.It is unlikely that the mitraclip device caused the patient¿s death.Given that the patient coded during placement of a chest tube, one must consider that there may have been an unrecognized complication which caused the code.If the patient had a correction of her hypoxia of treatment of the ast, it is unlikely that this was a continuing contributor to the patient¿s death.It is possible that the patient¿s comorbidities couple with the hypoxia event caused a cascade of events which contributed to her demise.Per records provided, the cause of death at this time has not been determined by the physicians.¿.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 16179394
• MDR Text Key: 307453838
• Report Number: 2135147-2023-00206
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20629R135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 95 KG