MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP NTR; VALVE REPAIR

Catalog Number CDS0602-NTR

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 05/12/2020

Event Type  Death  

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 the reported event.Based on the available information, the reported death was due to reported ventricular tachycardia; however, a definitive cause for the reported ventricular tachycardia could not be determined.The reported patient effect of death as listed in the mitraclip system instructions for use (ifu), 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 is being filed to report the ventricular tachycardia and death.It was reported that the initial mitraclip procedure was performed on (b)(6) 2020, to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to <1.The patient died on (b)(6) 2020 due to ventricular tachycardia.In the physicians opinion, the death was not related to the mitraclip device or procedure.No additional information was provided.

• Brand Name: MITRACLIP NTR
• 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: 10133427
• MDR Text Key: 194491203
• Report Number: 2024168-2020-04819
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/09/2020

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: 09/15/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 90914U242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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): Death