MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0705

Device Problem Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 02/03/2024

Event Type  Injury  

Event Description

It was reported that on 03 february 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.Mitraclip ntw (lot: 30508r1067) was advanced to the valve.Gripper orientation was not performed and the clip was advanced into the ventricle before imaging was optimized in peripheral view.After grasping, both grippers failed to lower.Also during grasping, the steerable guide catheter slipped out of the septum into the right atrium and caused an atrial septal defect (asd).The clip was then attempted to be retracted to the left atrium, but it became stuck in the chordae and could not be removed via standard troubleshooting.Non-standard troubleshooting was also attempted, such as shaking the clip which was also unsuccessful.The clip had to be implanted a2/p2 lateral with both leaflets and chordae.After deployment, the mean pressure gradient was 7 mmhg and blood pressure dropped, with mr remained unchanged grade 4.The mitral stenosis was too severe for the patient to endure so an intra-aortic balloon pump (iabp) was placed and the patient was put on extracorporeal membrane oxygenation (ecmo).The next day (b)(6) 2024, a mitral valve replacement surgery was performed, along with an atrial septal defect closure.

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 complaints reported from this lot.Based on available information, a cause of the reported unintended movement, associated with the steerable guide catheter slipping out of the septum into the right atrium, could not be determined.The reported perforation (atrial septal defect/ asd) was due to the sgc slippage.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• 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: 18739781
• MDR Text Key: 335764438
• Report Number: 2135147-2024-00746
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0705
• Device Lot Number: 30905R1049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 53 KG