MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0301

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

Patient Problems Thrombosis (2100); Atrial Perforation (2511)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).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 the information reviewed, the reported atrial septal defect (asd) in this incident appears to be related to patient morphology/pathology and/or user technique/procedural conditions; and unrelated to the device since there was no reported device issue/malfunction during the procedure.There was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effect of atrial perforation and thrombosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report thrombus, atrial perforation, and medical intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted that dilatation was performed prior to the procedure.The transseptal puncture was performed, and a steerable guide catheter (sgc) was advanced to the mitral valve.One clip was deployed, reducing mr.However, when the sgc was retracted back across the septum, the atrial septal defect looked considerably larger.The physician stated that the atrial perforation may have occurred during dilatation, but this could not be confirmed.Additionally, clotting was observed in the left atrial appendage indicating thrombosis; therefore, the patient was kept heparinized.The atrial perforation was successfully closed with an amplatzer closure device.The patient is stable.One clip was implanted, reducing mr to 1+.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9225116
• MDR Text Key: 164093019
• Report Number: 2024168-2019-12854
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90727U255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 54