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

Catalog Number CDS0602-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Weakness (2145); Heart Failure (2206)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The reported patient effects of worsening mitral regurgitation, dyspnea and worsening heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.It is possible that the patient anatomy (retracted posterior leaflet, prolapsed anterior leaflet, enlarged atrium) contributed to the reported slda; however this cannot be confirmed.The reported mitral regurgitation, dyspnea, weakness (physical) and heart failure were likely the result of the slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported that this was a mitraclip performed on (b)(6) 2019 to treat mixed mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing the mr to 1+.On (b)(6) 2019, the patient was hospitalized with dyspnea, weakness, worsening heart failure.Echocardiogram was performed and it was noted that the clip detached from the posterior leaflet, and remained attached to the anterior leaflet (slda) and mr increased to 4.Cardiac surgery will be performed.There was no additional information provided.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9270023
• MDR Text Key: 164832061
• Report Number: 2024168-2019-13133
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2019

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: 02/12/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90212U196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization