MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927615250

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

Patient Problems Intimal Dissection (1333); Death (1802); Perforation of Vessels (2135)

Event Date 03/24/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that there was vessel dissection and vessel rupture that led to patient death.The target lesion was located in the moderately tortuous proximal to mid left anterior descending artery (lad).This was a high risk percutaneous coronary intervention case where the patient was already on a temporary ventricular assisting device.Rotablation was performed without complication after which intravascular ultrasound (ivus) was completed with an opticross.A 2.50mm x 15mm nc emerge® balloon catheter was selected to further prepare the lesion.After predilation, a dissection was seen in the proximal lad.This was imaged with the opticross and it was observed the proximal lad was ruptured right below the left circumflex artery (lcx) ¿ lad bifurcation very close to the proximal lad.The proximal lad vessel diameter was greater than 3mm as seen on ivus.A stent graft was used to cover from the left main to proximal lad.The flow to the lcx was re-opened through the stent graft and the perforation was under control.The physician continued to treat the lcx with synergy stents.After stenting and post-dilation, it was found that the stent graft could not stop the bleeding from the proximal lad completely.The case was completed and the patient was placed under observation.About 6 hours later, the patient became unstable and was brought for open heart repair 3 hours after that.The patient subsequently passed away the following day.The official cause of death is not available.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6491440
• MDR Text Key: 72776387
• Report Number: 2134265-2017-03466
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: SIMILAR
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H7493927615250
• Device Catalogue Number: 39276-1525
• Device Lot Number: 0019920503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• 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): Death; Required Intervention