MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

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

Patient Problem Perforation (2001)

Event Date 09/09/2020

Event Type  Injury  

Event Description

This is filed to report the atrial septal defect.A case report was reported via literature that a mitraclip procedure was performed on a patient with severe functional mitral regurgitation (mr).A mitraclip had been implanted.Immediately post-procedure, the mr remained as there was a single leaflet device attachment (slda).Cardiac insufficiency symptoms were observed, requiring hospital admission.71 days following the mitraclip procedure, surgical intervention was performed, including a mitral valve replacement, prophylactic tricuspid annuloplasty (tap), left atrial appendage closure, and atrial septal foramen closure, leaving the patient in good condition.

Manufacturer Narrative

Date of event ¿ estimated.The steerable guide catheter was not reported to be returning for analysis.A follow-up report will be submitted with all additional relevant information.The other adverse events possibly related to the clip are filed under a separate medwatch report number.The other case referenced were filed under medwatch reports 2024168-2020-07719-01 and 2024168-2020-07719-00na.

Manufacturer Narrative

The device was not returned.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 effect of perforation as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The investigation was unable to determine a cause for the reported perforation.The reported hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B3: date of event.

Event Description

Subsequent to the previous report, the additional information was received: a case report was reported via literature that on (b)(6) 2020, a mitraclip procedure was performed on a patient with severe functional mitral regurgitation (mr).Two mitraclips (cds0502, 00210u180, 00210u177) were implanted.On 09/09/2020, a single leaflet device attachment (slda) was noted with one of the two mitraclips (cds0502, 00210u180).The tap procedure performed was a thoracotomy, not tricuspid annuloplasty.That same day on (b)(6) 2020, the mitraclips were explanted during the mitral valve replacement.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442-4628 ; 6517565400
• MDR Report Key: 14959558
• MDR Text Key: 295526843
• Report Number: 2024168-2022-07387
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00213U341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male