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

Catalog Number UNK SGC

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

Patient Problems Hypoxia (1918); Perforation (2001)

Event Date 09/18/2023

Event Type  Injury  

Event Description

This is filed to report a perforation.It was reported that a mitraclip procedure was performed to treat severer mitral regurgitation (mr), chronic heart failure, enlarged heart, and prolapsed mid-posterior mitral leaflet.After an atrial transseptal puncture, a slight right-to-left shunt appeared on transesophageal echocardiography.A mitraclip was implanted in the a2/p2 segment.Transesophageal echocardiography showed that the residual mr was mild without mitral stenosis.Although the mitraclip was successful, hemodynamics did not improve.Immediately after removing the steerable guide catheter (sgc), a right-to-left shunt developed continuously and there was a decrease in oxygenation.An amplatzer atrial septal defect occluder was implanted in the shunt with no reported issue.The occlusion was successful, and the oxygen increased.Despite inotropic and intra-aortic balloon pump (iabp) support, the patient remained in cardiogenic shock.Despite unloading pulmonary circulation by transcatheter mitral valve edge-to-edge repair (teer), the patient still suffered from pulmonary hypertension (ph) and right ventricular (rv) failure.When inhaled nitric acid (ino) was administered without any other additional anesthetic interventions, hemodynamics improved dramatically in few minutes.The patient was transferred from the operating room to the intensive care unit.The patient was withdrawn from iabp support on postoperative day 2.Administration of ino was stopped, and the patient was extubated on postoperative day 3.The patient was discharged from the intensive care unit on postoperative day 7 without major complications.No additional information was provided.

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported perforation appears to be due to procedural conditions.The reported hypoxia appears to be a cascading effect of the reported perforation.Additionally, the reported patient effect of perforation is listed in the instructions for use and is a known possible complication associated with mitraclip procedures.The reported medical interventions were the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 17940572
• MDR Text Key: 325745569
• Report Number: 2135147-2023-04519
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 60 KG