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

Catalog Number SGC0302

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511); Pericardial Effusion (3271)

Event Date 05/18/2020

Event Type  Death  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report unintended movement, pericardial effusion and death. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. Prior to the procedure, it was noted that the patient presented to the hospital with late presentation myocardial infarction and developed papillary muscle rupture and flail of the posterior leaflet. It was noted that the patient was intubated and placed on intra-aortic balloon pump (iabp) and inotropic support. The physician decided to continue with a mitraclip procedure; therefore, the steerable guide catheter (sgc) was inserted. However, while removing the guide wire, due to tension on the device, the sgc slightly moved forward. It was then noticed that, the patients blood pressure decreased. A pericardial effusion was noted immediately after. Emergency pericardiocentesis was performed; however, no significant reduction of the effusion occurred. The decision was made to open the chest by surgery. A large holed was then noted at the base of the left atrium (la) appendage and was attributed to the insertion of the sgc. The patient then passed away due to the pericardial effusion. There was no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: MITRACLIP SYSTEM 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: 10128924
• MDR Text Key: 194343380
• Report Number: 2024168-2020-04786
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/24/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00225U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/08/2020 Patient Sequence Number: 1