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); High Blood Pressure/ Hypertension (1908); Atrial Perforation (2511)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the reported atrial perforation likely resulting in hypertension and hemorrhage appears to be related to user technique/procedural circumstances.The reported patient effect of atrial septal defect (atrial perforation), hypertension and hemorrhage 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 filed to report the steerable guide catheter (sgc) caused an iatrogenic atrial septal defect.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.The clip delivery system (cds) was advanced to the mitral valve and the clip was implanted, reducing mr to 1-2.The patient had a history of atrial septal defect (asd) and blood flowed from left atrium to right atrium before procedure.Because the asd was present pre-procedure, the steerable guide catheter (sgc) was inserted from another site in the atrial septum.However, when the steerable guide catheter (sgc) was pulled to the right atrium, iatrogenic asd was generated and the amount of blood flowing through the left atrium to right atrium increased.As amounts of bleeding increased from femoral vein during the procedure, blood transfusion was performed.Nevertheless, stable blood pressure could not be obtained without the use of vasopressors.There was confirmation of no pericardial effusion of chordae tendineae, increased mr or mitral stenosis.The pulmonary blood flow ratio increase, so it was decided to insert a percutaneous cardiopulmonary support (pcps) to support the heart function.After inserting the pcps, the patient was transferred without extubating to another hospital to close the asd.However, the asd closure was not performed since hemodynamic stability and the location of the asd was determined to be difficult to place on arrival to the hospital.Th patient is currently undergoing rehabilitation after being extubated and will be discharged from the hospital and is in good condition.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: 10038704
• MDR Text Key: 190334432
• Report Number: 2024168-2020-04183
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91101U258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 52