MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-XTR

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

Patient Problems Mitral Regurgitation (1964); Heart Failure (2206); Test Result (2695)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).This report is filed for worsening mitral regurgitation and worsening heart failure.It was reported that on (b)(6) 2019, one mitraclip (cds0601-xtr, lot # 81210u253) was implanted without a device issue, reducing degenerative mitral regurgitation (mr) from grade 3+ to grade 1+.On (b)(6) 2019, during a follow-up echocardiogram, the mr had increased to grade 2+.Per physician, the increase in mr was related to physiological variations and was unrelated to the mitraclip device.The mitraclip remained stable and well seated.There was no device malfunction and no tissue injury.On (b)(6) 2019, the patient was hospitalized for worsening heart failure and severe mitral regurgitation.Worsening of pre-existing dilated cardiomyopathy and left ventricular function (15-20%) were also observed.As treatment for the worsening mr, another mitraclip procedure was performed.A second clip was attempted; however, the mean pressure gradient was deemed too high, therefore, the clip was not deployed and was removed without issue.Medications were provided for the worsening heart failure with the goal of diuresis.Reportedly, the index procedure mitraclip remained stable and well seated.There was no device related tissue injury.On (b)(6) 2020, a left ventricular assist device (lvad) was implanted and patent foramen ovale closure was performed.Medications had been provided.The patient was in stable condition.Reportedly, the residual mr, dilated cardiomyopathy, reduced left ventricular ejection fraction (lvef), worsening heart failure, and treatments of, are possibly related to the implanted clip (cds0601-xtr, lot # 81210u253).The clip had remained stable and well seated without tissue injury.There was no device malfunction reported with any mitraclip device.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for analysis.In this case, there was no reported device malfunction associated with the clip delivery system (cds).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on information reviewed, a definitive cause for heart failure and mitral regurgitation (mr) could not be determined.It is possible that worsening of the patients pre-existing dilated cardiomyopathy and left ventricular function (15-20%) resulted in reported condition, however it cannot be confirmed.The additional therapy/non-surgical treatment and hospitalization was a result of case specific circumstances as a left ventricular assist device (lvad) was implanted.Treatment with medication (s) was a result of case specific circumstances as medications were provided for the worsening heart failure, test results ((reduced left ventricular ejection fraction (lvef)) appears to be related to patient condition.The reported patient effects of mr and heart failure are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effect(s), and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.G3 corrected.

Event Description

Subsequent to the previously filed report, the additional information was received: per the physician, the residual mitral regurgitation (mr), dilated cardiomyopathy, reduced left ventricular ejection fraction (lvef), worsening heart failure, and treatments of, are possibly related to the implanted clip, cds0601-xtr, lot # 81210u253.The clip remained stable and well seated on the leaflets.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9836679
• MDR Text Key: 186568252
• Report Number: 2024168-2020-02477
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 81210U253
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 86