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

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

Patient Problem Aortic Dissection (2491)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: agilis introducer, swartz introducer.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 aortic root puncture could not be conclusively determined.Per the ifu, aortic dissection is a known risk during the use of this device.

Event Description

Related manufacturing ref: 2182269-2019-00242, 3005334138-2019-00648.The following was published in the european society of cardiology in an article titled, "inadvertent transseptal puncture into the aortic root: the narrow edge between luck and catastrophe in interventional cardiology" by hao chen, et al.On 18 march 2019 regarding a multi-center study presenting experiences of unintentional aortic root puncture (arp) and clinical management occurring in 20 years of practicing transseptal puncture (tsp): all patients with arp were retrospectively collected from seven hospitals.Aortic root puncture was identified and classified regarding angiographical and intraoperative findings in cardiac surgery: (i) tsp from the right atrium (ra) to the non-coronary sinus (ncs), (ii) tsp from ra to the non-coronary sinutubular junction (stj), and (iii) tsp from ra to the ascending aorta (aa).A total of 24 patients with inadvertent arp were identified.In 19 patients, penetration of the aorta was accomplished by the inner dilator, in 5 patients by the complete sheath.Previous cardiac surgery had been performed in six patients.There were 13 ra-to-ncs punctures, 2 ra-to-stj punctures, and 9 ra-to-aa punctures.No cardiac tamponade (ct) occurred in patients with ra-to-ncs and ra-to-stj punctures.In 8 of 9 patients with ra-to-aa puncture, ct occurred immediately requiring urgent pericardiocentesis and surgical repair.Two patients died after surgical repair.In the 16 patients without surgical therapy, no shunt from the ar to the ra was observed 3 months after the procedure.The two deaths were due to vt electric storm 10 days post procedure and multi-organ failure and pneumonia 84 days post procedure.They were not attributed to the aortic root puncture.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 9409708
• MDR Text Key: 169031863
• Report Number: 3008452825-2019-00594
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072278
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention