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

Catalog Number CDS0502

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

Patient Problem Atrial Tachycardia (1731)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed for atrial tachycardia.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ with a restricted posterior leaflet and a dilated left atrium.One mitraclip was deployed at a2/p2 medial portion.A second mitraclip (90729u134) was deployed at a2/p2 lateral portion, reducing mr to 1-2.Once the clip delivery system (cds) was retracted, atrial tachycardia was noted.After the procedure, cardioversion was performed and the heart rate returned to sinus rhythm.The patient is doing well and stable.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effect of arrhythmias (tachycardia), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All information was investigated, and a cause for the reported atrial tachycardia could not be determined.Although a conclusive cause for the reported patient effect, and the relationship to the device, if any, cannot 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
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9549402
• MDR Text Key: 177774715
• Report Number: 2024168-2020-00252
• 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: 01/09/2020

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: 07/29/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90729U134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 43