MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the leak requiring additional aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed.The cds was being removed from the steerable guide catheter (sgc); however, the stopcock of the clip introducer was not closed properly, and air entered the hemostatic valve of the sgc.The stopcock on the clip introducer was re-closed, and aspiration was performed to prevent air from entering the patient.Another clip was deployed to further reduce mr.Two clips were implanted, reducing mr to <1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was not returned.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to the reported event.The reported leak appears to be related to the loose or intermittent connection of the stopcock, however a definitive cause for the loose or intermittent connection of the stopcock could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8582137
• MDR Text Key: 144132436
• Report Number: 2024168-2019-03547
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80914U109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2019
• Date Manufacturer Received: 08/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 54