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

Catalog Number CDS0502

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Air Embolism (1697)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report air embolism, leak, and delay.It was reported that this was a mitraclip procedure to treat mitral functional regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve; however, during the deployment sequence, a small amount of saline was observed to be leaking between the flush port of the steerable sleeve and the three-way stop cock.The three way stop cock was loose; and therefore, re-closed.Echocardiogram confirmed air around the apex of the left ventricle causing a clinically significant delay in the procedure.A decision was made not perform additional treatment and monitor the condition of the patient.The clip was deployed.Approximately one hour later, the air decreased about 50% or less.Since air entered the left ventricular, the heart team is planning on what the next course of treatment will be.One clip was implanted, reducing mr to 1-2.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leaks and loose or intermittent connection (flush port to stopcock) could not be confirmed via returned device 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 similar complaints reported from this lot.The investigation determined the reported leaks appears to be related to the reported loose connection between the flush port and stopcock.However, a cause for the loose connection cannot be determined.The air embolism appears to be due to the procedural condition of the leaks.The patient effect of air embolism is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported delayed therapy/non-surgical treatment was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10357683
• MDR Text Key: 201503440
• Report Number: 2024168-2020-06429
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00212U163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 76 YR