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

Model Number H7493911616350

Device Problem Occlusion Within Device (1423)

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

Event Date 08/10/2017

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

It was reported that patient experienced chest pain and in-stent restenosis occurred.In (b)(6) 2012, the patient was referred for cardiac catheterization.Coronary angiography and the index procedure were performed.Target lesion #1 was located in the proximal right coronary artery (rca) with 70% in-stent restenosis (isr) of the previously placed stent and was 5mm long with a reference vessel diameter of 3.5mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50x12mm promus element¿ plus drug-eluting stent (des).Following post dilatation, residual stenosis was 0% and timi 3 flow noted.Target lesion #2 was located in the mid rca with 70% isr of the previously placed stent and was 5mm long with a reference vessel diameter of 3.5mm.Target lesion #2 was treated with pre dilatation and placement of a 3.50x16mm promus element¿ plus des.Following post dilation, residual stenosis was 0% timi 3 flow noted.A day post-procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to the emergency department with the complaint of severe chest pain radiating to left jaw and upper arm and was hospitalized on the same day.The patient was monitored for cardiac enzymes and electrocardiogram (ecg).Since the patient had negative troponin and ecg but had persistent chest pain the patient was referred for catheterization.Four days after, cardiac catheterization was performed.Due to the patient's recent diagnosis of myelodysplastic syndrome it was decided to medically manage his chest pain.Three days after, the patient was discharged home.In (b)(6) 2017, the patient presented with complaints of worsening chest, arm and jaw pain and shortness of breath.The myocardial perfusion imaging test revealed a filling defect in the inferior wall with hypokinesis of the inferior wall.The patent was referred for cardiac catheterization which revealed the rca had 50% proximal stenosis and irregular mid 70-80% in-stent restenosis (isr of study stent).On the same day, based on above mentioned angiography findings a diagnosis of coronary artery disease was confirmed and patient was referred for percutaneous coronary intervention (pci).The isr in the mid rca was treated with a 3.5 x 16mm synergy des with 0% residual stenosis.The next day, the event was considered resolved and the patient was discharged.

• 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: 7626169
• MDR Text Key: 111916002
• Report Number: 2134265-2018-05581
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Model Number: H7493911616350
• Device Catalogue Number: 39116-1635
• Device Lot Number: 0015092482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2012
• 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: 61 YR