MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0705

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Perforation (2001)

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.One clip was successfully implanted, reducing the mr to a grade of <1.However, after removal of the steerable guide catheter (sgc), a right to left shunt was observed.It was noted that blood pressure and oxygen saturation (spo2) gradually decreased, the sgc was reinserted into the left atrium to suppress the shunt blood flow.Both blood pressure and spo2 increased.Once the external doctor arrived, an atrial septal defect (asd) closure device was implanted.There was no clinically significant delay in the procedure.

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 available information, the cause of the reported perforation was unable to be determined.The reported hypoxia and hypotension were cascading events of the reported perforation.The reported patient effects of perforation and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• 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: 18779473
• MDR Text Key: 336234669
• Report Number: 2135147-2024-00862
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0705
• Device Lot Number: 31003R1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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: IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 42 KG