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

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271); Unspecified Tissue Injury (4559)

Event Date 04/14/2022

Event Type  Death  

Event Description

This is filed to report the steerable guide catheter advancing too far hitting the left atrial appendage or wall, pericardial effusion requiring intervention and patient death.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.One mitraclip was successfully implanted without issue, reducing the mr to a grade of 2-3.A clip delivery system (cds) was advanced to the mitral valve, but it was noted that imaging was difficult.It was hard to visualize the posterior mitral leaflet (pml) and grasping was unsuccessful.The clip was inverted and pulled out of the left ventricle (lv).Curves were removed using the m knob and the cds moved grossly due to a chord being stuck in the clip.The chord gave way and the device popped back hitting the lateral wall or roof of the left atrium.As a result, the physician lost access to the left atrium.While advancing the steerable guide catheter (sgc) back through the septum there was resistance and tenting noted.The stabilizer plate was pushed forward, which may have inadvertently advanced the sgc too far, hitting the lateral wall or left atrial appendage (laa).However, tissue damage could not be confirmed on echo and fluoro.At this point in the procedure, a pericardial effusion was noted and the patient¿s blood pressure dropped; therefore, the clip was removed from the patient.Cardiac tamponade was confirmed, and the physician began to treat the pericardial effusion by performing a pericardiocentesis and providing medication with some chest compressions.The physician was prepared to perform surgery to stop the bleeding within the pericardial sac, however, the family did not want the patient to undergo surgery and the patient died.The cause of death was due to the pericardial effusion.It was noted that the pericardial effusion could have been caused by the cds or sgc.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device is filed under separate medwatch report number.

Event Description

N/a.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, a cause for the reported difficulty advancing the steerable guide catheter (sgc) through the septum could not be determined.A cause of the reported poor imaging could not be determined.A cause of the reported tissue injury could not be determined.The reported pericardial effusion appears to be related to the difficulty advancing the sgc through the septum.The reported hypotension and cardiac tamponade were secondary effects of the reported pericardial effusion.The reported death was due to the pericardial effusion.The reported patient effects of tissue injury, pericardial effusion, hypotension, cardiac tamponade and death as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions (pericardiocentesis, chest compressions), medication required and delay to treatment/ therapy were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.In addition, the event was further reviewed by an abbott medical affairs team.The reviewer stated that ¿the cause of death was pericardial effusion.Death was not directly related to the device but the atrial injury was likely related to the device and triggered the cascade of events leading to death.¿.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• 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 Key: 14279561
• MDR Text Key: 290655546
• Report Number: 2024168-2022-04797
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0701
• Device Lot Number: 11201R239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: 83 YR
• Patient Sex: Female