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

Model Number CDS0701-XTW

Device Problems Product Quality Problem (1506); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2022

Event Type  Death  

Event Description

User facility medwatch report received that states "abbott mitraclip g4 system failed.Non smoker, non drinker." on (b)(6) 2021, xtw (10515r285) was implanted.On (b)(6) 2022, a device failure occurred that led to the death of the patient.No additional information was provided.

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 incidents reported from this lot.Based on available information, the cause of the reported product quality problem (unknown damage) and patient death could not be determined.The reported patient effect of death as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

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 incidents reported from this lot.Based on available information, the cause of the reported patient effects (recurrent mr, dyspnea, and death) could not be determined as the amount of information provided was insufficient.The reported patient effects of mr, dyspnea, and death as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a patient death.User facility medwatch report received that states "abbott mitraclip g4 system failed.Non smoker, non drinker." it was reported that on (b)(6) 2021 a mitraclip procedure was performed to treat mitral regurgitation.One clip was implanted with no reported issue.On or around (b)(6) 2022, the patient was admitted to the hospital due to shortness of breath.Echocardiogram showed no issue with the heart or the clip.The patient was given oxygen and released.On or around (b)(6) 2022, the patient was admitted due to difficulty breathing.The physician noted that there was a recurrent mr ¿the valve was leaking a bit¿.Since the patient was weak, she was transferred to rehab.On or around (b)(6) 2022, another physician reportedly told the family that the mitraclip failed and that they could not do anything further to treat the patient.The patient was barely conscious at this point, reportedly due to weakness.The patient was released on (b)(6) 2022.On (b)(6) 2022, the patient expired.Patient had stage 4 kidney disease.In the physician¿s opinion, no complications were noted pre, during or post procedure.Patient was doing fine.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16796313
• MDR Text Key: 313834381
• Report Number: 2135147-2023-01770
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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: 05/14/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10515R285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• 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): Death