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

Model Number CDS0601-XTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Cardiac Enzyme Elevation (1838); Seizures (2063)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of cerebrovascular accident, and air embolism, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the cause for the reported embolism resulting in enzyme elevation, stroke resulting in seizures cannot be determined.Although a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the stroke.It was reported the mitraclip procedure was performed on (b)(6) 2020 to treat grade 4 degenerative mitral regurgitation.The first clip was implanted without issues.To further reduce mr, a second clip was advanced to the mitral valve.Imaging was challenging due to shadowing from the first clip.The leaflets could not be grasped due to the commissural location and chordal interaction, but was freed from the chordae without causing injury.Air emboli was seen in the left atrium.It is unknown where the air came from, no air bubbles were seen in any of the devices.The patient experienced st elevation due to the air emboli.No medication was given and was reduced to 3.Initially, post-procedure, the patient was doing fine, but early the next morning, the patient experienced a stroke and a seizure and was put on a ventilator.It is unknown if the mitraclip device or procedure caused or contributed to the stroke and seizure.No additional information was provided.

• Brand Name: MITRACLIP XTR 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: 10099363
• MDR Text Key: 193072111
• Report Number: 2024168-2020-04596
• 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: 05/28/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 91125U229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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; Disability
• Patient Age: 92 YR