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

Catalog Number SGC0302

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

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 the reported event.Based on available information, the reported pericardial effusion, hypotension, and hemorrhage were due to procedural conditions.The cardiac tamponade was a cascading event of the pericardial effusion.The reported patient effects of pericardial effusion, cardiac tamponade, hemorrhage, and hypotension are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatment, treatment with medication, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the pericardial effusion requiring treatment.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After advancement of the steerable guide catheter (sgc) into the left atrium (la), the patients blood pressure dropped and a pericardial effusion was noted.The pericardial effusion was punctured and treated immediately so that the patient became stable again and the procedure continued.The sgc and clip delivery system (cds) were positioned in the la.During the course of the procedure, the anesthetist administered medication to the patient as the patient's hemodynamics deteriorated, and the patient developed bleeding over the tube in the neck.The anesthesiologist mentioned that the patient was becoming more and more unstable.In addition, the imaging got worse and it was no longer possible to align the cds correctly in the la to implant it.The physician decided to abort the procedure, with the mr remaining at 3-4.The patient was subjected to an emergency bronchoscopy while on the operating table and it was determined that the patient had a lung cancer that was also unknown at the time and that began to bleed heavily when given heaprin.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: 10843468
• MDR Text Key: 216347452
• Report Number: 2024168-2020-09550
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00820U132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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: MITRACLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention