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

Catalog Number CDS0601-XTR

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2019

Event Type  Injury  

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 in this incident could not be determined.The reported gripper line break was a result of the reported mechanical jam.The reported foreign body in patient was related to a part of the gripper line being left behind in the patient.The reported patient effect of foreign body in patient as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is being filed to report the inability to remove the gripper line and break resulting in the gripper line left in the body.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve and the leaflets grasped.During deployment, the gripper line (gl) was removed approximately 25% and then it stopped.The gl broke half way out of the patient.The cds was removed and troubleshooting was performed with smaller/different sheaths/catheters but the line was eventually cut at the groin and left in the patient.The procedure was completed with the mr reduced to <1.There was a clinically significant delay in the procedure due to the reported issue.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: 9526770
• MDR Text Key: 174901530
• Report Number: 2024168-2019-15039
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 12/27/2019

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: 07/24/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90724U245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 61