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

Model Number H7493911416350

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985)

Event Date 02/28/2017

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

Same case as mdr id: 2134265-2018-03130 (b)(6) study.It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented with mi without st elevation (nstemi) and unstable angina.The patient was referred for cardiac catheterization.Subsequently, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in proximal right coronary artery (rca) extending to mid rca with 99% stenosis and was 30mm long with a reference vessel diameter of 4.0mm.The target lesion was treated with direct stent placement of a 3.00x24mm and 3.50x16.00mm promus element¿ plus stents with 0% residual stenosis.After three days, the patient was discharged on aspirin and prasugrel.In (b)(6) 2017, the patient presented to emergency room with complaints of central chest pain.The patient described the chest pain as a stabbing sensation associated with dyspnea on exertion and nausea.The patient also experienced fall at home.Subsequently, patient was hospitalized on the same day for further evaluation.In (b)(6) 2017, 80% discrete in-stent stenosis in mid rca was treated with predilatation and placement of 3.5 x 23 non-bsc drug-eluting stent.Following post dilatation the residual stenosis was 0%.Additionally, the patient received medication therapy in response to the event.On the following day, the event was considered as 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 - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7558012
• MDR Text Key: 109699427
• Report Number: 2134265-2018-05398
• 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: 05/16/2018

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: 03/06/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 0015172721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2012
• 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: 65 YR