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

Catalog Number UNK SGC03

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

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Heart Failure (2206); Atrial Perforation (2511)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information provided the reported atrial perforation is a result of procedural conditions.The reported heart failure is a result of the atrial perforation.A conclusive cause for the reported hypertension and dyspnea cannot be determined.The patient effects of atrial perforation, heart failure, hypertension and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.The other additional two devices referenced is being filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation and heart failure.It was reported that through a research article that roughly three years ago, a mitraclip procedure was performed to treat mitral regurgitation (mr).The procedure was successfully performed, but a 28mm amplatzer atrial septal occluder (aso) was used in order to close a large atrial septal defect (asd).Roughly two years later, the patient returned to the hospital and echocardiogram showed that mr had increase to a grade of 4.Therefore, a second mitraclip procedure was performed.It was noted that transseptal access was achieved through the previously implanted closure device.Two additional mitraclip were successfully implanted, reducing mr to a grade of 1+.It was noted that the hole made through the aso was not closed due to the possibility of an additional procedure and the potential for the unloading of the left atrial hypertension.One month later, the patient returned to the hospital with heart failure symptoms.The decision was made to use a 14mm amplatzer closure device to close the new asd.The patient health was noted to have improved.One year later, the patient had a follow up appointment and echocardiogram confirmed mr remained at a grade of 1+; however, mild dyspnea was noted.It was noted that the second closure device was well seated with a minimal residual shunt.See attached article for additional information.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9756535
• MDR Text Key: 183093010
• Report Number: 2024168-2020-01779
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR