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

Catalog Number SGC0301

Device Problems Positioning Failure (1158); Deformation Due to Compressive Stress (2889)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report material deformation, heart failure, requiring intervention it was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4 and prolapsed anterior leaflet.A steerable guide catheter (sgc) was used but while inserting the mitraclip, it was not possible to adjust the bending of the sgc.The tip of the sgc was bent.While attempting to bend the sgc, the patient had heart failure.The patient was given adrenaline and cardiopulmonary resuscitation (cpr) was performed.The procedure was abandoned, and no clips were implanted.The mr remained at grade 4.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Analysis of the returned device was unable to confirm the reported positioning failure associated with tip deflection (unable to curve the steerable guide catheter/sgc).The reported deformation due to compressive stress however, was confirmed as the shaft was observed to be kinked.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on information provided and the results of the returned device analysis a cause for the inability to curve tip and kinked shaft could not be determined.Additionally, a cause for the reported heart failure cannot be determined.Heart failure is a known possible complication associated with mitraclip procedures.Unexpected medical intervention and medication required were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 17413643
• MDR Text Key: 320019278
• Report Number: 2135147-2023-03299
• Device Sequence Number: 1
• Product Code: DRA
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2024
• Device Catalogue Number: SGC0301
• Device Lot Number: 30327R1048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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: 1 MITRACLIP
• Patient Outcome(s): Other; Required Intervention