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

Catalog Number CDS0602-NTR

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hematoma (1884); Cardiac Tamponade (2226); Atrial Perforation (2511)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a cardiac tamponade, atrial perforation and hematoma.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.An ntr clip delivery system (cds) was prepped per ifu and inserted into the anatomy; however, it was noted that due to the anatomy, maneuvering was difficult, which caused the clip to contact the atrial wall creating a hole in the left atrium (la).Echocardiogram then showed a cardiac tamponade had occurred.Emergency pericardiocentesis was performed to treat the cardiac tamponade.A massive pericardial hematoma was then observed; therefore, a sternotomy was performed, causing a clinically significant delay in the procedure.The physician then decided to abort the procedure.Mr remained at a grade of 3-4.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 this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the information provided the reported difficult positioning is the result of patient anatomy.The reported cardiac tamponade and atrial perforation were results of the difficult positioning.The reported hematoma was a result of the atrial perforation.The reported patient effects of cardiac tamponade, hematoma and atrial perforation, as listed in the mitraclip system instructions for use, are 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 SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9659654
• MDR Text Key: 178019044
• Report Number: 2024168-2020-01120
• Device Sequence Number: 1
• Product Code: NKM
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 90926U214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention