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

Model Number H7493927612270

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.  (b)(4).  device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.    (b)(4).

Event Description

Same case as mdr id as: 2134265-2018-03511 and 2134265-2018-03510.It was reported that vessel dissection and balloon rupture occurred.On an unknown data, approximately 13 years prior to the reported event, a 3.0 x 28 mm taxus liberte paclitaxel-eluting coronary stent was implanted in the left circumflex artery (lcx).Vascular access was obtained via the right femoral and right radial arteries.The 80% stenosed, 3.0 mm x 28 mm,concentric, in-stent restenosis (isr) was located in a moderately tortuous and moderately calcified lcx.There was a significance bend in the lesion between 45 and 90 degrees.A 2.0 x 20 mm emerge balloon catheter was advanced for dilatation followed by a 10/2.50 flextome¿ cutting balloon¿ which failed to cross the lesion.The physician then attempted to use a 2.75 mm x 12 mm nc emerge® balloon catheter to further dilate the lesion but during the second inflation at 14 atmospheres the balloon ruptured and a slight dissection was noted within the taxus liberte stent.The lesion was dilated with a 2.5 x 12 mm nc emerge® balloon catheter and a new 2.75 x 12 mm nc emerge® balloon catheter.However, during the second inflation at 14 atmospheres, the 2.75 x 12 mm balloon also ruptured.A 2.75 x 32 mm synergy drug-eluting stent was successfully deployed and post dilated with a 3.25 x 12 mm nc emerge® balloon catheter.Intravascular ultrasound ( ivus) was used to optimize post percutaneous coronary intervention and no dissection was observed.No further patient complications were reported and the patient's status was stable.

• 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: 7422640
• MDR Text Key: 105196722
• Report Number: 2134265-2018-03505
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: H7493927612270
• Device Catalogue Number: 39276-1227
• Device Lot Number: 21383601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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): Required Intervention