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

Catalog Number SGC0701

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

Patient Problem Perforation (2001)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

The two mitraclips mentioned in b5 and d10 are being filed under separate medwatch report numbers.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.The investigation was unable to determine a cause for the reported perforation.Perforation is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported surgical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This report is being filed against the steerable guide catheter due to the clinically significant atrial septal defect.Crd_947 - repair mr ide study patient id: (b)(6).It was reported that on (b)(6) 202, the patient presented with degenerative mitral regurgitation (mr) with an enlarged left atrium and posterior flail.Two mitraclips were successfully delivered and deployed, reducing the mr to grade 1+.On (b)(6) 2024, residual, moderate to severe mr was noted.Reportedly, it was thought that the medial mitraclip had slipped off the posterior leaflet.This was observed on a later date.There was no single leaflet device attachment (slda).On (b)(6) 2024, the patient presented to the emergency department with chest pain and atrial fibrillation.On (b)(6) 2024, the patient was seen by the cardiologist for progressive dyspnea on exertion, lower extremity edema, a new cough, orthopnea, paroxysmal nocturnal dyspnea, and severe mr was noted.On (b)(6) 2024, the patient presented with dyspnea, hypotension, mr, and worsening acute heart failure was diagnosed.The patient was admitted to cardiology for treatment.The patient was also covid positive.Medications had been provided.Per imaging, the medial mitraclip had slipped off the posterior leaflet.There was no slda noted.On (b)(6) 2024, a deep vein thrombosis (dvt) of the lower extremity was noted.On (b)(6) 2024, per imaging, acute infarcts were observed within the cranium and a cerebrovascular accident (cva-stroke) was diagnosed, likely cardioembolic.There was no acute intracranial hemorrhage.Per physician, the dvt and stroke were unrelated to the mitraclip device.On (b)(6) 2024, moderate to severe mr was noted and a mitral valve replacement was performed.Additional procedures performed included a left atrial maze (for atrial fibrillation) and closure of the left atrial appendage (laa) and atrial septal defect (asd) was performed.Reportedly, once the clips were removed, there was both anterior and posterior leaflet endothelial damage.The tissue injury was associated with both mitraclips.Per physician, the atrial fibrillation treated with maze was unrelated to the mitraclip device.The asd was deemed related to the steerable guide catheter related and had been closed during the surgery.

• 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: 18924088
• MDR Text Key: 337904525
• Report Number: 2135147-2024-01206
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 31107R1090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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: 2 MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White