MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0705-NT

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

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the suspected air embolism.It was reported this was a mitrclip procedure performed to treat grade 3+ functional mitral regurgitation (mr).During clip deployment, when removing the lock cap, it is suspected air entered the patient because st elevation went up and the patients¿ blood pressure dropped to approximately 60mmhg.Blood pressure returned to normal pressure over time.No treatment, medication or intervention were required for the st elevation or for the drop in blood pressure.Myocardial infarction was not diagnosed.The clip was implanted, and mr was reduced to 1.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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.Based on available information, the cause of the reported air embolism is due to procedural conditions.The reported hypotension and ekg/ecg changes are cascading effects of the reported air embolism.Additionally, the reported hypotension and air embolism are listed in the mitraclip system instructions for use and are known possible complications associated with mitraclip procedures.The serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: removed health effect - clinical code 1838.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 14069845
• MDR Text Key: 288985474
• Report Number: 2024168-2022-03835
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

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: 07/11/2022
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 10630R169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 51 KG