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 Cardiac Arrest (1762); Atrial Perforation (2511)

Event Date 10/21/2019

Event Type  Death  

Manufacturer Narrative

Exemption number e2019001.The device location was not provided and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report atrial perforation, cardiac arrest, medical intervention, and death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.On (b)(6) 2019, a steerable guide catheter (sgc) was advanced to the mitral valve, and two clips were successfully deployed, reducing mr to 1-2.On (b)(6) 2019, the patient underwent a second mitraclip procedure due to increased mr of grade 4.One additional clip was implanted, reducing mr to 2.The two previously implanted clips remain stable on the leaflets.The physician stated that patient had a minor left to right shunting during the initial procedure that was expected to close on its own.But, during the second procedure, it was observed that the atrial perforation did not close on its own; and therefore an unspecified closure device was used to treat the atrial perforation.Then later that night, the patient went into cardiac arrest due to the atrial perforation.Cardiopulmonary resuscitation (cpr) was performed and then an extracorporeal membrane oxygenation (ecmo) was placed.On (b)(6) 2019, the patient was taken off life support and died.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: on (b)(6) 2019, two clips (90611u135, 90812u128) were successfully deployed.On 11/21/2019, a 30 day followup revealed that the patient had shortness of breath and it was discovered that the patient's mitral regurgitation increased.The physician stated that the shortness of breath and recurrent mitral regurgitation was due to disease of progression.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the available information, the reported atrial perforation was due to the initial procedure as the perforation did not close on its own.The reported cardiac arrest was a cascading effect of the reported atrial perforation and the attempt to close it with a closure device.The reported patient death was unrelated to mitraclip device or procedure and was because the patient was taken off life support two days after the second mitraclip procedure, therefore, a cascading effect of the reported cardiac arrest and patient condition.The reported patient effects of death, atrial septal defect requiring intervention and cardiac arrest 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.

• 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: 9495184
• MDR Text Key: 172007308
• Report Number: 2024168-2019-14743
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90820U105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP; 2 IMPLANTED MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 95