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

Catalog Number UNK SGC

Device Problem Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 04/17/2023

Event Type  Injury  

Event Description

This is filed to report failure to advance the steerable guide catheter, causing an atrial septal defect.It was reported in an article that a patient underwent a mitraclip procedure to treat severe degenerative mitral regurgitation (mr) with flail of the lateral (p1) leaflet.The mitraclip system was noted to have an anterior-to-posterior trajectory (aorta hugger).The aorta hugger could not be corrected, requiring another transseptal puncture.A repeat transseptal puncture was performed with a height of 5.8 cm.While advancing the steerable guide catheter across the interatrial septum through the second transseptal puncture, a septal tear was noted, extending to the first transseptal puncture, thereby again resulting in loss of height from the mitral valve.It was decided to abort the procedure.No additional information was provided.Details are listed in the attached article titled, ¿transcatheter edge-to-edge repair with the pascal device for failed mitraclip procedure¿.

Manufacturer Narrative

Date of event is estimated.The udi number is not known as the part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) review and complaint history review were not performed because this incident was based on an article review and no lot information was provided.Based on available information, the reported failure to advance (low transseptal puncture) appears to be due to the tissue tear as the greater height could not be maintained at the second puncture site.A cause of the reported perforation (septal tear extended to the first puncture) could not be determined.The reported patient effect of perforation as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: article titled, "transcatheter edge-to-edge repair with the pascal device for failed mitraclip procedure".

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 16961337
• MDR Text Key: 315553765
• Report Number: 2135147-2023-02211
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Male