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

Model Number CDS0701-XT

Device Problem Unintended Movement (3026)

Patient Problems Atrial Fibrillation (1729); Mitral Regurgitation (1964); Rupture (2208); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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 slda referenced will be filed under a separate medwatch mfr number.

Event Description

This is filed to report the clip failed the final arm angle (efaa) test.It was reported that on (b)(6) 2021, a mitraclip procedure was performed to treat functional mitral regurgitation (mr), with an mr grade of 4.Imaging was challenging due to the anatomy.The first clip was implanted without issues.To further reduce mr, a second clip was advanced to the mitral valve.The clip would not stay locked during the final arm angle (efaa) test.After some additional troubleshooting, efaa was successful, the clips stayed locked and was implanted without further issue.A total of two clips were implanted, reducing mr to 2.On (b)(6) 2021, follow up transesophageal echocardiography (tee) was performed showing mitral regurgitation (mr) had increased from 2 to 4.The clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), and a chordae rupture was suspected.Surgical treatment is on hold, because the patient experienced an elevated white blood cell count and atrial fibrillation with rapid ventricular response (rvr).The patient was re-intubated and remains in intensive care.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified did not indicate a similar incident.All available information was investigated and a definitive cause for the reported issue of clip open-efaa could not be determined in this complaint.The reported poor image resolution appears to be related to anatomical challenge.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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11341188
• MDR Text Key: 233744172
• Report Number: 2024168-2021-01283
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 00818U250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X1); STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Weight: 46