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

Model Number CDS0701-NT

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

Patient Problems Death (1802); Cardiac Tamponade (2226); Atrial Perforation (2511); Pericardial Effusion (3271)

Event Date 11/03/2020

Event Type  Death  

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.Na.

Event Description

This is filed to report death, pericardial effusion, cardiac tamponade and atrial perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were implanted, reducing mr to a grade of 2-3.However, after the second clip (00413u169) was implanted, the patient became hypotensive.A perforation on the posterior wall and a pericardial effusion were then observed.It was suspected that the perforation and pericardial effusion were cased by the second clip.For treatment, pericardiocentesis was performed.Unfortunately, the pericardial effusion continued to occurred; therefore, the patient was transferred to emergency cardiac surgery.However, the patient passed away while attempting to treat the pericardial effusion.It was noted that an epicardial patch was attempted to be sewed on, but due to friable tissue, the patch was unable to adhere to the tissue.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on available information, the reported atrial perforation and pericardial effusion were caused by procedural circumstances.A cause for the reported cardiac tamponade and death could not be determined.Additionally, the reported pericardial effusion, cardiac tamponade, death, and atrial perforation are listed in the mitraclip instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported surgical procedure, hospitalization, and pericardiocentesis are the result of case-specific circumstances, as the patient was reported hospitalized, pericardiocentesis was performed and the patient was transferred to emergency cardiac surgery due to the reported issues.There is no indication of a product issue with respect to manufacture, design, or labelingna.

• 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: 10899538
• MDR Text Key: 218154589
• Report Number: 2024168-2020-09887
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: 12/23/2020

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: 04/14/2021
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 00413U169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 78