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

Model Number H7493911408250

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985); Obstruction/Occlusion (2422)

Event Date 04/18/2015

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.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 relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id#: 2134265-2017-00299.(b)(4) clinical study.It was reported that in-stent restenosis (isr) and non-st segment elevation myocardial infarction (nstemi) occurred.In (b)(6) 2013, index procedure was performed.Target lesion was a de novo lesion located in the mid left anterior descending artery (lad) with 80% stenosis and was 22 mm long with a reference vessel diameter of 2.75 mm.Target lesion was treated with pre-dilatation and placement of a 2.50 mm x 16 mm and 2.50 mm x 8 mm promus element¿ plus drug-eluting stents (des) in overlapping manner.Following post dilatation residual stenosis was 0%.The following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient presented to the emergency department (ed) with the complaint of chest pain.The patient described the pain as a tight sub sternal pressure that radiates to both shoulders with associated shortness of breath.Electrocardiogram (ecg) revealed atrial fibrillation with rapid ventricular response; anterolateral st-t changes are nonspecific.On the same day, cardiac enzymes were noted to be elevated.The elevated level of cardiac enzyme along with ecg changes suggested acute ischemia and the site has reported an event of nstemi.The patient was started on iv heparin and nitroglycerin drip for nstemi and was referred for cardiac catheterization.The next day, a 99% isr of the middle of the stents in the mid portion with a very sluggish flow and a mild 30% stenosis in the mid segment of the 2nd diagonal were noted.The 99% isr located in mid lad was treated with pre-dilatation and placement of 2.5 mm x 26 mm, 3.00 mm x 22 mm and 3.00 mm x 22 mm non-bsc des in overlapping manner with 0% residual stenosis.The following day, the event was considered as resolved and the patient was discharged on aspirin and prasugrel.

• 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: 6278663
• MDR Text Key: 65767592
• Report Number: 2134265-2017-00300
• 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: 01/06/2017

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: 07/30/2013
• Device Model Number: H7493911408250
• Device Catalogue Number: 39114-0825
• Device Lot Number: 0015513222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2012
• 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: 71 YR