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

Catalog Number CDS0705-NT

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

Patient Problems Air Embolism (1697); Angina (1710); Ischemia (1942); Nausea (1970)

Event Date 05/13/2021

Event Type  Injury  

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.Date of event is estimated.Date of implant is estimated.Article titled ¿takotsubo syndrome after transcatheter mitral valve repair.¿.

Event Description

This is filed to report air embolism.It was reported through a research article that an (b)(6)-old patient present with severe mitral regurgitation (mr) and underwent a transcatheter mitral valve repair (tmvr).It was noted the patient presented with posterior leaflet prolapse and atrial fibrillation.One nt clip was successfully placed on the mitral valve.However, roughly four hours after the procedure, the patient developed sudden nausea, chest distress and ischemia.It was suspected the patient effects may have caused by a coronary air embolism, but that was unable to be confirmed.However, based on the international takotsubo registry criteria, it was confirmed the patient had takotsubo syndrome (tts).The article concluded by stating it was suspected the patients physiological stress was the main cause of the tts.Additional details are listed in the article, titled ¿takotsubo syndrome after transcatheter mitral valve repair.¿ no additional information was provided.

Manufacturer Narrative

The product was not returned for analysis.The lot history record review and similar complaint review were not performed because this incident was based on a review article, and no lot information was provided.Based on the limited information provided, a cause for the reported nausea, angina, ischemia, and air embolism cannot be determined.The reported patient effects of nausea, angina, ischemia, and air embolism are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.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
• 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: 12896849
• MDR Text Key: 281430491
• Report Number: 2024168-2021-10883
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: CDS0705-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 86 YR
• Patient Sex: Female