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

Catalog Number UNK CDS

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

Patient Problems Dyspnea (1816); Edema (1820); Heart Failure (2206); Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant estimated.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot and part information were not provided.The reported patient effects of heart failure, edema, dyspnea, cardiogenic shock as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a cause for reported heart failure could not be determined.The reported edema, dyspnea and cardiogenic shock appear to be cascading effects of heart failure.Although a conclusive cause for the reported patient effects, 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.

Event Description

Patient id (b)(6).It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr).On an unspecified date post mitraclip procedure, the patient experienced increasing dyspnea, increased body weight and edema.Cardiac decompensation was diagnosed and the patient was re-hospitalized.During hospitalization, the patient went into cardiogenic shock and the symptoms worsened.Catecholamine was administered.On 06/06/2020, the patient was transferred to a heart center for further evaluation.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.In this case, there was no reported device malfunction associated with the clip delivery system (cds).It was reported that study physician has deemed this event as unrelated to the study device or study procedure.Based on the overall information, there is no indication of product issue with respect to manufacture, design or labeling.H6: health effect - clinical codes: 1816, 1820, 2206, 2262 - removed.H6: investigation findings: code 213 - removed.H6: investigation conclusions: code 22 - removed.

Event Description

Subsequent to the initial report, additional information was received, indicating that the adverse event resolved with sequelae.Additionally, the study physician has deemed this event as unrelated to the study device or study procedure.This event has been reported; therefore, it will remain reportable for mdr reporting.No additional information provided.

• 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: 10003603
• MDR Text Key: 190006768
• Report Number: 2024168-2020-03942
• Device Sequence Number: 1
• Product Code: NKM
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83