MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911408250

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

Patient Problems Dyspnea (1816); Occlusion (1984); Dizziness (2194)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

(b)(6) clinical study.It was reported that coronary artery restenosis occurred.In (b)(6) 2013, the index procedure was performed.The target lesion was a de novo lesion located in the proximal left circumflex (lcx) artery with 95% stenosis and was 6mm long with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50x8mm study stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to the hospital with symptoms of shortness of breath and dizziness on exertion that would be relieved by rest.The patient underwent a stress study that was abnormal, revealing ischemia in the anterior and inferior walls suggestive of coronary artery disease.The patient was further referred for cardiac catheterization to rule out obstructive coronary artery disease.The following day, coronary angiography was performed.On the same day, the 99% calcified stenosis located in the proximal lcx was treated with balloon angioplasty and placement of a 3.5x38mm synergy stent.Post procedure, the stenosis was 0% with timi 3 flow.There were no post procedural complications noted.The following day, the event was considered as resolved.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 6623341
• MDR Text Key: 77212746
• Report Number: 2134265-2017-05972
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2017

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
• Device Expiration Date: 05/31/2013
• Device Model Number: H7493911408250
• Device Catalogue Number: 39114-0825
• Device Lot Number: 0015373800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2012
• 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
• Patient Age: 51 YR