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

Catalog Number CDS0502

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

Patient Problem Ventricular Tachycardia (2132)

Event Date 02/17/2020

Event Type  Injury  

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.The investigation determined the reported ventricular tachycardia appears to be related to patient morphology/pathology.The reported patient effect of ventricular tachycardia, 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 issue with respect to manufacture, design or labeling.

Event Description

This will be filed to report during the procedure, the patient experienced ventricular tachycardia requiring medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.The patient had ventricular tachycardia (vt) prior to the procedure.Two clips were implanted reducing mr to <1.During the procedure, vt continued to occur; therefore, a cardioverter defibrillator was placed to treat the vt.There was no issue with the mitraclip devices during the procedure.No additional information was reported.

• Brand Name: MITRACLIP SYSTEM 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: 9813608
• MDR Text Key: 184263740
• Report Number: 2024168-2020-02234
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2020

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: 08/26/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90824U122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 58 YR