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 Problem Heart Failure (2206)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date: estimated.The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The deaths and product problems mentioned are filed under different mfr report numbers.

Event Description

This is filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, heart failure, re-hospitalization, medical intervention, and surgical intervention.Device issues include, single leaflet device attachment (slda) and inability to grasp.Details are listed in the article, titled ¿prognostic value of pre-operative atrial fibrillation in patients with secondary mitral regurgitation undergoing mitraclip implantation.¿.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records could not be performed due to unknown lot information.Additionally, a review of the complaint histories could not be performed due to unknown lot information.The reported patient effects of heart failure, as listed in the mitraclip system instructions for use is known possible complication associated with mitraclip procedures the cause for the reported cases of heart failure could not be determined.The reported re-hospitalizations, additional therapy/non-surgical treatments (pti and additional procedure mitral valve) and surgical procedures were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 11189948
• MDR Text Key: 227512858
• Report Number: 2024168-2021-00550
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 01/04/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR