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

Catalog Number CDS0601-NTR

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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 issues.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.All available information was investigated, and a definite cause for the reported mechanical jam could not be determined.The reported gripper line break was a result of the reported mechanical jam.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report the gripper line break.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.Resistance was felt when inserting the first steerable guide catheter (sgc), into the groin, so the vein was further dilated and a new sgc was advanced without issues.The mitraclip delivery system (cds) was advanced and the clip was placed; however, when flossing the gripper line (gl), only one end of the gl moved and the other end of the gl did not move; thus, the gripper line was noted to be broken.Clip deployment was continued and the gl was removed by hand from the two separate ends.No portion of the gl remained in the patient.The clip remained secure on the leaflets.A total of three clips were implanted, reducing mr to 1-2.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was 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: 9532544
• MDR Text Key: 178162323
• Report Number: 2024168-2019-15082
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2020
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90418U135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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