MAUDE Adverse Event Report: ABBOTT VASCULAR G4 MITRACLIP CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

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

Patient Problems Stroke/CVA (1770); Visual Disturbances (2140)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record did not identify any manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the reported cerebrovascular accident and visual disturbances were due to procedural circumstances.The reported patient effect of stroke as listed in the mitraclip gen 4 system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the procedural stroke.Patient id: (b)(4).It was reported that on (b)(6) 2020 two mitraclips were implanted in the patient.The same day, the patient had diplopia and blurry vision in the setting of a punctate infarct in the left cerebellar hemisphere as found by a brain magnetic resonance imaging (mri).This was diagnosed as an ischemic stroke.The patient was treated with a heparin drip on (b)(6) 2020.The condition is ongoing.No additional information was provided.

Event Description

This is filed to report the procedural stroke.Patient id: (b)(6).It was reported that on (b)(6) 2020 two mitraclips were implanted in the patient.The same day, the patient had diplopia and blurry vision in the setting of a punctate infarct in the left cerebellar hemisphere as found by a brain magnetic resonance imaging (mri).This was diagnosed as an ischemic stroke.The patient was treated with a heparin drip on (b)(6) 2020.The condition is ongoing.Subsequent to the previously filed report, additional information was received that the patient condition resolved on (b)(6) 2020, but the patient still had some symptoms such as arm, face, and leg weakness.The patient is able to move and perform daily activities independently.No additional information was provided.

• Brand Name: G4 MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10195914
• MDR Text Key: 196455083
• Report Number: 2024168-2020-05327
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Expiration Date: 12/03/2020
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 91205U117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 77