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

Model Number UNK731

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

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969)

Event Date 01/13/2018

Event Type  Death  

Manufacturer Narrative

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#2134265-2018-00872, 2134265-2018-01625, 2134265-2018-01626, and 2134265-2018-01628. It was reported that st elevation myocardial infarction (stemi) and death occurred. A 4. 00mmx32mm synergy stent was advanced but was unable to cross the target lesion. At some time during the procedure three emerge balloons, a 2. 00x20mm, a 3. 0x20mm, and a 3. 0x30mm, were used along with a 3. 5x15mm nc quantum balloon. The patient was reported to have experienced stemi and subsequently died.

Manufacturer Narrative

(b)(4).

Event Description

Also same case as mdr# 2134265-2018-02211. Previously it was reported that st elevation myocardial infarction (stemi) occurred during the procedure but now it is reported the patient presented with stemi. It was further reported that the 100% stenosed target lesion was located in a severely calcified, non-tortuous, mid to distal right coronary artery (rca). The 3. 0x20mm emerge balloon was used first, followed by the 3. 0x30mm and 2. 0x20mm emerge balloons, and the 3. 5x15mm nc quantum balloon. Prior to the patient's death, angioplasty, thrombectomy, and stenting with a 3. 5 x 32 synergy ii stent were performed. The patient died due to cardiac arrest. The physician did not consider the patient's death to be related to these devices.

• Brand Name: 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: 7278348
• MDR Text Key: 100318193
• Report Number: 2134265-2018-01627
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNK731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/16/2018 Patient Sequence Number: 1