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

Model Number N/A

Device Problems Break (1069); Positioning Failure (1158); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

This is filed to report the gripper actuation issue and one side of the gripper being broken.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The patient had a flailing posterior leaflet.Due to challenging anatomy, grasping was attempted multiple times but failed to secure both leaflets simultaneously with the grippers.It was suspected that there was damage to the gripper.The clip delivery system xtw (ref: cds0705-xtw, sn: (b)(4)) was removed and examined outside the patient's body.It was confirmed that one side of the grippers was broken.A new xtw clip was prepared (ref: cds0705-xtw, sn: (b)(4)) and during which the echocardiologist found that there was suspected thrombus attached to the tip of the steerable guide catheter (ref: sgc0705, sn: (b)(4)).The steerable guide catheter was removed while light aspiration applied along the way.The thrombus was not seen on transesophageal echocardiography after removing the guide and it was determined that the thrombus had been removed along with the guide.The procedure was resumed with a new set of sgc (sgc0705 sn: (b)(4)) and clip (xtw) and the implanters successfully grasped the leaflets.However, the post-clipping evaluation revealed an elevated transmitral gradient of 8mmhg.Repositioning of the clip still showed high gradient with more residual mr.The team decided to switch to xt clip to save as much valve area without trading off the mr reduction by the longer clip arms.The xtw system was then replaced by the xt system (cds0705-xt, sn:(b)(4)).The implanters eventually grasped the leaflets by xt clip with acceptable transmitral gradient (4mmhg) and achieved good mr reduction at <1.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The steerable guide catheter referenced is filed under a separate medwatch report number.

Manufacturer Narrative

A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The returned device analysis confirmed the reported gripper line break and inability to raise a single gripper.The reported failure to capture leaflets could not be replicated in a testing environment based on all available information, the failure to capture leaflets appears to be due to challenging patient anatomy.The broken gripper line appears to be due to procedural conditions.The reported single gripper actuation issue is a cascading event of the broken gripper line there is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15194222
• MDR Text Key: 305259895
• Report Number: 2135147-2022-00699
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 10920R187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2021
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian