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

Model Number H7493911608300

Device Problems Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)

Patient Problems Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Diaphoresis (2452)

Event Date 12/31/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).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 information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.Same case as mfr report#: 2134265-2017-00214, 2134265-2017-00216, 2134265-2017-00217.It was reported that following a coronary artery drug eluting stenting treatment procedure, myocardial infarction (mi), stent thrombosis (st), and incomplete stent apposition occurred.In (b)(6) 2012, the patient presented due to myocardial infarction and unstable angina (braunwald¿s classification) and was referred for cardiac catheterization.The de novo target lesion was located in the distal right coronary artery (dist rca) with 90% stenosis and was 22 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilation and placement of a 3.00 x 20 mm promus element plus stent and a 3.00 x 8 mm promus element plus stent in overlapping fashion, with 0% residual stenosis following post-dilation.The patient was discharged on aspirin and clopidogrel the next day.In (b)(6) 2016, the patient presented with chest pain associated with diaphoresis and mild shortness of breath.Subsequently the patient was referred for cardiac catheterization.One- hundred percent (100%) stent thrombosis at dist rca was noted and a samurai guidewire was placed in the vessel which resulted in distal embolization of the thrombus to the posterolateral branch.The under expansion of previously placed study stents in dist rca was then treated with balloon angioplasty and placement of a 3.5 x 16 mm synergy ii drug-eluting stent in an overlapping fashion with previously placed study stent.Following post-dilation the overlapping segment with the previously placed study stent still appeared to be under expanded.This was treated with further balloon dilation using a 4 x 15 mm quantum maverick balloon.The event was considered as resolved and the patient was discharged on dual antiplatelet therapy the next day.

• 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: 6290595
• MDR Text Key: 66184851
• Report Number: 2134265-2017-00215
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2012
• Device Model Number: H7493911608300
• Device Catalogue Number: 39116-0830
• Device Lot Number: 0014987604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2012
• 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: 65 YR