MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problems Myocardial Infarction (1969); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported cardiac perforation, myocardial infarction remains unknown.Concomitant device:fast-cath introducer.

Event Description

Related manufacturing ref: 3005334138-2021-00340.The following was posted in the department of cardiology, rabin medical center, 39 jabotinsky st., petach tikva 4941492, israel; and affiliated to the faculty of medicine, tel aviv university, tel aviv, israel received 24 october 2020; first decision 8 december 2021; accepted 9 april 2021 "management of ascending aorta perforation during transseptal puncture for left atrial appendage closure: a case report".An (b)(6) female with a history of atrial fibrillation and repeated episodes of major bleeding on direct oral anticoagulant therapy, with a high risk for thromboembolism and was referred for left atrial appendage closure.The procedure was performed under transesophageal echocardiography (tee) guidance.There was no left atrial appendage thrombus.Transseptal puncture was performed by the brk-1 xs needle and swartz sl1 transseptal guiding introducer.However, during transseptal puncture, no clear tenting of the septum was visualized under tee guidance.Following transseptal puncture, intraprocedural tee showed a perforation into the ascending aorta had occurred, with the sheath placed in the ascending aorta.This was confirmed with aortic pressure signals and contrast fluoroscopy.The patient was hemodynamically stable and there was no evidence of a pericardial effusion on tee.This perforation was closed percutaneously using an amplatzer duct occluder (ado).Reversal of heparinization with protamine sulphate was given to avoid intractable bleeding.However, this resulted in thrombus formation and subsequent embolization causing an st-elevation myocardial infarction.This was treated with balloon dilation and thrombus aspiration with subsequent thrombolysis in myocardial infarction 3 flow.The patient stabilized within a few hours and the intra-aortic balloon pump was removed.The patient was discharged within a few days.Following the procedure, the patient was treated with 3 months of clopidogrel therapy at a dose of 75mg daily, together with long-term low-dose apixaban (2.5mg twice daily).Five months later, the patient was re-admitted due to generalized weakness.Her hemoglobin had remained stable and an echocardiogram showed the ado in situ.She was diagnosed with a metastatic lymphoproliferative malignancy and died shortly thereafter.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11862114
• MDR Text Key: 255606987
• Report Number: 3008452825-2021-00301
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention