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

Model Number	H7493911438400
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
(b)(6) clinical study.It was reported that myocardial infarction and restenosis occurred.In (b)(6) 2012, the patient presented due to unstable angina and myocardial infarction.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the saphenous vein graft (svg ) to 2nd obtuse marginal (om2) with 95% stenosis and was 28mm long with reference vessel diameter of 4.00mm.The target lesion was treated with direct placement of a 4.00x38mm promus element¿ plus drug eluting stent.Following post-dilatation residual stenosis was 0%.Two days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient came to emergency department with chest pain radiating down his left arm.Slng completely resolved the symptoms.On the same day, chest x-ray revealed right lower lobe (rll) atelectasis and small effusion.Electrocardiography (ecg) showed no acute changes.The patient was hospitalized.Cardiac enzymes were noted to be elevated and the site reported the event of non-st elevation myocardial infarction (nstemi).The patient was referred for catheterization.The chronic total occlusion in the mid svg to om2 happened in (b)(6) 2015 was not treated at that time and still persist at the time of nstemi.Additionally, the 90% stenosis of svg to diagonal graft which was the culprit lesion for non q wave mi was treated with placement of a 2.5x18 mm non-bsc drug eluting stent followed by 0% residual stenosis.The outcome to the event was considered as resolved and the patient was discharged.
Additional Manufacturer Narrative
Bsc id: (b)(4).
Event or Problem Description
It was further reported that stent thrombosis of svg to om2 occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6967349
• Report Number: 2134265-2017-10383
• Device Sequence Number: 1184601
• Product Code: NIQ
• UDI-Device Identifier: 08714729823773
• UDI-Public: 08714729823773
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: H7493911438400
• Device Catalogue Number: 39114-3840
• Device Lot Number: 15091331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR