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 Problems Air Embolism (1697); Stroke/CVA (1770); Thrombosis (2100); Weakness (2145)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of cerebrovascular accident, thrombosis, weakness and air embolism as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The investigation determined the reported paresis appears to be related to the cerebral infarction.However, a conclusive cause for the cerebral infarction, thrombus, and air embolism cannot be determined.It is possible that patient conditions contributed to cerebral infarction, thrombus, and air embolism; however, this cannot be confirmed.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report cerebral infarction.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.One mitraclip was implanted, reducing mr to <1.On (b)(6) 2019, after the patient woke from anesthesia, a cerebral infarction was confirmed with ct imaging.Paresis in the left lower limb was noted.The in the physician's opinion, a thrombus and an air embolism that occurred during the procedure could be the cause of the infarction.However, the thrombus and air embolism were not confirmed.Heparin was continued and edaravone was administered as treatment for the cerebral infarction.The paresis is almost resolved, however a light paresis of the left lower limb is still present.There was no clinically significant delay in the procedure.Hospitalization was prolonged.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: 9496907
• MDR Text Key: 175672014
• Report Number: 2024168-2019-14759
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/19/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90429U149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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; Disability
• Patient Age: 71 YR
• Patient Weight: 22