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 Problems Respiratory Failure (2484); Pericardial Effusion (3271)

Event Date 12/05/2023

Event Type  Injury  

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.Based on available information, the cause of the reported respiratory failure and pericardial effusion were unable to be determined.The reported patient effects of pericardial effusion and respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

This report is being filed due to a pericardial effusion and respiratory failure, possibly related to the steerable guide catheter.Crd_947 - repair mr ide study patient id: (b)(6) it was reported that on (b)(6) 2023, the patient presented with degenerative mitral regurgitation with anterior leaflet prolapse.Three mitraclips, two xtw and one ntw were successfully implanted, reducing the mr to grade 1+.There was no device malfunction at this time.On (b)(6) 2023, the patient was hospitalized, hypotensive, and went into cardiogenic shock due to mr.Medications were provided and another echocardiogram was performed.Severe mr, along with a single leaflet device attachment (slda) with one of the three mitraclips and a partial flail segment of the anterior leaflet was observed.During this hospitalization, respiratory failure with a moderate pericardial effusion were noted.No additional treatment was provided.Per physician, the effusion was possibly related to the mitraclip delivery system and possibly related to the steerable guide catheter.The patient was placed on do not resuscitate orders and passed away on (b)(6) 2023.The preliminary cause of death was mr.

• 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: 18812774
• MDR Text Key: 336620871
• Report Number: 2135147-2024-00946
• Device Sequence Number: 1
• Product Code: DRA
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 30921R1085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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: THREE MITRACLIPS
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White