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

Model Number H7493911412220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Chest Pain (1776); Dyspnea (1816); Nausea (1970); Occlusion (1984); Diaphoresis (2452)

Event Date 01/05/2017

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.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

(b)(6) clinical study.It was reported that chest pain and target lesion restenosis occurred.In (b)(6) 2012, the patient presented due to stable angina (ccs classification 4) and was referred for coronary angiography.Subsequently, index procedure was performed.The target lesion was located in the distal aspect of a saphenous vein graft (svg) to 1st diagonal with 90% stenosis and was 8mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with direct stent placement using a 2.25mmx12mm promus element¿ plus stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2017, the patient experienced exertional chest pain and pressure associated with shortness of breath and dyspnea on exertion.It was relieved with rest associated with diaphoresis and nausea.The symptoms were consistent with ccc4 angina.On the following day, the patient was hospitalized and coronary angiography revealed occluded svg to 1st diagonal.99% stenosis of mid svg to right coronary artery (rca) was treated with placement of a 4x20mm synergy drug-eluting stent (des) with 0% residual stenosis.Additionally, 80% distal stenosis of left main coronary artery (lmca) into left circumflex artery (lcx) was treated with placement of a 2.25x12 mm synergy drug eluting stent with 0% residual stenosis.One day later, the event was considered resolved and the patient was discharged on aspirin and ticagrelor.

• 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: 6297924
• MDR Text Key: 66432974
• Report Number: 2134265-2017-00521
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: H7493911412220
• Device Catalogue Number: 39114-1222
• Device Lot Number: 0015435304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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: 44 YR