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

Model Number H7493911616250

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Chest Pain (1776); Reocclusion (1985)

Event Date 11/06/2017

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 investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) clinical study.It was reported that chest discomfort and in-stent restenosis occurred.In (b)(6) 2013, the subject presented with silent ischemia and was diagnosed with stable angina.The subject was then referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was a de novo lesion located in the distal left circumflex artery (lcx) with 80% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation and placement of a 2.50 x 16 mm promus element¿ plus study stent.Following post-dilatation, residual stenosis was 0%.On the same day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2017, the subject presented with progressive accelerating exertional chest discomfort.Subsequently, the subject was hospitalized and coronary angiography was permed which revealed an 80% in-stent restenosis (isr) of the previously implanted 2.50 x 16 mm promus element¿ plus study stent in distal lcx.The stress test performed on the same day revealed distal, anterior, apical and posterolateral lateral wall ischemia.The subject was hospitalized and referred for cardiac catheterization.The 80% isr of distal lcx was treated with pre-dilation and placement of 2.25 x 32 mm synergy drug eluting stent within the previously placed proximal and distal stents.Following post-dilatation, residual stenosis was 0%.The following day, subject was discharged in stable ambulatory condition.

Manufacturer Narrative

Describe event or problem, relevant tests/lab data, other relevant history, and patient code updated.(b)(4).

Event Description

It was further reported that the patient had progressive angina and slight elevation of troponin.

• 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: 7409162
• MDR Text Key: 104762907
• Report Number: 2134265-2018-02816
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807360
• UDI-Public: 08714729807360
• 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,Followup
• Report Date: 03/16/2018

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: 01/22/2013
• Device Model Number: H7493911616250
• Device Catalogue Number: 39116-1625
• Device Lot Number: 0015058086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR