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

Catalog Number UNK CDS

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Respiratory Distress (2045); Ventricular Fibrillation (2130); Heart Failure (2206); Cardiac Tamponade (2226); Cardiogenic Shock (2262)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: estimated dates.(udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported patient effects of cardiac arrest, cardiogenic shock, renal failure, cerebrovascular accident, hemorrhage, cardiac tamponade, ventricular fibrillation, heart failure, arrhythmia, and respiratory distress could not be determined.The reported patient effects of cardiac arrest, cardiogenic shock, renal failure, cerebrovascular accident, hemorrhage, cardiac tamponade, ventricular fibrillation, heart failure, arrhythmia, and respiratory distress are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature article title ¿transcatheter edge-to-edge repair with mitraclip in systolic heart failure with ischemic versus nonischemic cardiomyopathy.¿.

Event Description

This is being filed to report cardiac arrest, cardiogenic shock, use of mechanical circulatory support, acute kidney injury, acute stroke, major bleeding, cardiac tamponade, blood transfusion, respiratory complications, ventricular arrhythmias, complete heart block, permanent pacemaker insertion, heart failure, and hospitalization.It was reported through a research article identifying mitraclip that may be related to patient cardiac arrest, cardiogenic shock, use of mechanical circulatory support, acute kidney injury, acute stroke, major bleeding, cardiac tamponade, blood transfusion, respiratory complications, ventricular arrhythmias, complete heart block, permanent pacemaker insertion, heart failure, and hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article: transcatheter edge-to-edge repair with mitraclip in systolic heart failure with ischemic versus nonischemic cardiomyopathy.No additional information was provided.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11091089
• MDR Text Key: 224781706
• Report Number: 2024168-2020-10969
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2020

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Disability