MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problem Incomplete Coaptation (2507)

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

Event Date 02/09/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot specific product issue.The reported patient effects of dyspnea, weakness and mitral regurgitation as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported single leaflet device attachment/slda could not be determined.The recurrent mitral regurgitation/mr was due to the slda.Moreover, weakness and dyspnea were reportedly present prior to procedure and are due to challenging patient morphology/pathology.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 the mitraclip procedure was performed on (b)(6) 2020 to treat functional mitral regurgitation (mr) with a grade of 4.There were some difficulties with visualization, due to the patient anatomy one clip was implanted, reducing mr to 1.Two days following the procedure ((b)(6) 2020), while the patient was still at the hospital, the patient experienced dyspnea and reduced exercise capacity, similar symptoms he had prior to the procedure.Echocardiogram was performed, the clip had detached from the short posterior leaflet and remained attached to the anterior leaflet (slda).Mr increased to 4.The patient remained hospitalized with intravenous diuretics and was discharged on day five with some improvement.There was conversation with the family about the possibility of implantation of a second clip at a later date.No additional information was provided.

• Brand Name: MITRACLIP XTR
• 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: 10359793
• MDR Text Key: 201503956
• Report Number: 2024168-2020-06458
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

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: 12/09/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 91210U173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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; Required Intervention