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

Model Number N/A

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

Patient Problems Pulmonary Embolism (1498); Hypoxia (1918)

Event Date 08/29/2022

Event Type  Injury  

Event Description

This is filed to report pulmonary embolism.It was reported that on (b)(6) 2022, the patient presented with functional mitral regurgitation (mr) grade 4+.During the septal puncture to access the left atrium, the right ventricle (rv) showed a slight enlargement.Treatment continued, however, the patient¿s oxygenation levels (spo2) decreased and further expansion of the rv was observed.A pulmonary embolism (pe) was diagnosed.The procedure was discontinued, and no clip had been implanted.The mr remained unchanged at grade 4+.Per physician, the event was unrelated to the device, and it was most likely caused by the patient's history of deep vein thrombosis (dvt).There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Manufacturer Narrative

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 the information reviewed, the reported pulmonary embolism resulting in hypoxia appears to be due to patient conditions (enlargement of the right ventricle and dvt).The reported serious injury/illness/impairment was a result of case-specific circumstances.Pulmonary embolism is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15595800
• MDR Text Key: 301652377
• Report Number: 2135147-2022-01290
• 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: 11/28/2022

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: 03/07/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20307R142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 52 KG