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

Catalog Number SGC0301

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

Patient Problem Perforation (2001)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr), long prolapsed leaflet and restricted posterior leaflet for a mitraclip procedure.A transseptal puncture height of 3.7cm presented challenges in positioning the first clip (b)(6) near the posterior grasping location.The clip was able to be implanted.A second clip (b)(6) was placed and closed.Upon evaluation, it was noted that mr was coming between the first and second clips.The grasp was released with the second clip and a single leaflet device attachment was noted with the first clip, and the anterior leaflet was detached.Within the next 3 hours remedial measures to stabilize the slda with the second clip were carried out, however; the anterior leaflet chordae tendineae was ruptured in the process (by the 2nd clip).A chordae rupture was also caused by the slda.The second clip was removed.Additionally, a large atrial septal defect was found upon withdrawal of the steerable guide catheter (sgc).No treatment was required for the asd.In the end, it was decided to discontinue the procedure.The mr was worsened to grade 5.There was no clinically significant delay.On (b)(6) 2024, surgery was performed and the slda clip was explanted.It was noted that the clip had pinched a portion of the chordae tendinea from the posterior leaflet.

Manufacturer Narrative

In this case, there was no functional testing for the returned device as no device malfunction was reported.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 patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported 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.

• 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: 18953056
• MDR Text Key: 338308461
• Report Number: 2135147-2024-01302
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)240723(10)30721R1008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161985
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0301
• Device Lot Number: 30721R1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• 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: MITRACLIP (X2); STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER AND MITRACLIP
• Patient Outcome(s): Other