MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Respiratory Failure (2484); Pericardial Effusion (3271); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 12/05/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed due to recurrent mitral regurgitation, a single leaflet device attachment, and hospitalization with shock and death.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 (mr) with anterior leaflet prolapse.Three mitraclips, two xtw mitraclips and one ntw mitraclip (cds0706-ntw, 30427r1094) 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 (cds0706-ntw, 30427r1094), and a partial flail segment of the anterior leaflet was observed.The patient was placed on do not resuscitate orders and passed away on (b)(6) 2023.The preliminary cause of death was mr.No additional information was provided regarding this issue.

Event Description

Subsequent to the initial report, the additional information was received: on (b)(6) 2023, while hospitalized with respiratory failure, a moderate pericardial effusion was 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.

Manufacturer Narrative

The steerable guide catheter mentioned in b5 is being filed under a separate report number.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, the cause of the reported single leaflet device attachment (slda) and tissue injury were unable to be determined.The reported recurrent mitral regurgitation (mr) was a cascading event of the reported slda.The reported death, shock, hypotension, respiratory failure, and pericardial effusion were likely cascading events of the reported recurrent mr.The reported patient effects of death, mitral regurgitation, tissue injury, hypotension, respiratory failure, and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 18408153
• MDR Text Key: 331471594
• Report Number: 2135147-2023-05741
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• 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,Followup
• Report Date: 02/29/2024

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 Expiration Date: 04/25/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30427R1094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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 IMPLANTED MITRACLIPS.
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White