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

Model Number H7493911416270

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Reocclusion (1985)

Event Date 03/18/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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 2134265-2016-00080.(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, coronary angiography and the index procedure were performed.Target lesion was a de novo lesion located in distal right coronary artery (rca) with 80% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with direct stent placement using a 2.25 x 16 mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the mid rca with 75% stenosis and was 14 mm long with a reference vessel diameter of 3.0 mm.Target lesion #2 was treated with direct stent placement using a 2.75 x 16 mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Post this procedure, slight disruption was noted in the proximal bend of the rca which was subsequently treated with balloon angioplasty and intracoronary nitroglycerin, with excellent results.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented with one month history of radiating chest pain associated with shortness of breath (sob) and for re-evaluation of coronary artery disease (cad).On the same day, electrocardiogram (ekg) showed no specific changes and the patient was referred for cardiac catheterization and was scheduled for a left heart catheterization.Two days later, the patient presented for a scheduled cardiac cath and was hospitalized on the same day.The patient was diagnosed with multivessel cad and was referred for coronary artery bypass graft (cabg).Seven days later, the patient underwent five vessel cabg including left internal mammary artery (lima) to left anterior descending (lad) artery, reverse saphenous vein graft (svg) to obtuse marginal (om1), reverse svg to ramus, reverse svg to posterior descending artery (pda), and reverse svg to posterior left ventricular (plv) branch.Six days later, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7428976
• MDR Text Key: 105410708
• Report Number: 2134265-2018-03690
• 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: 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: 08/05/2013
• Device Model Number: H7493911416270
• Device Catalogue Number: 39114-1627
• Device Lot Number: 0015522488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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: 56 YR