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 Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This will be filed to report during use of the steerable guide catheter, the patient experienced asystole for seconds which required cardiopulmonary resuscitation.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 3-4.After introduction of the steerable guide catheter (sgc), the patient experienced asystole for seconds, so cardiopulmonary resuscitation (cpr) was required for about 15 ¿ 20 seconds.The asystole occurred after the dilator and the guide wire had been removed.The procedure could be continued after exclusion of pericardial effusion and heart attack by a left-heart cathartic examination and was successfully completed.One clip was implanted, reducing mr to 1-2.The patient was cardiovascular stable after the event.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have resulted in this complaint.Based on the information reviewed, a conclusive cause for arrhythmia and cardiac arrest could not be determined in this complaint.Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined.The reported unexpected medical intervention appears to be due to case specific circumstances as cardiopulmonary resuscitation (cpr) was required for about 15 ¿ 20 seconds due to arrhythmia.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: 11602862
• MDR Text Key: 243402406
• Report Number: 2024168-2021-02621
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00919U140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention