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

Model Number H7493911420250

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

Patient Problems Angina (1710); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Occlusion (1984); Chest Tightness/Pressure (2463)

Event Date 07/24/2015

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

(b)(6).It was reported that restenosis and angina occurred.In (b)(6) 2013, the patient presented due to myocardial infarction (mi) and coronary angiography was performed.Target lesion #1 was a de novo lesion located in the proximal left circumflex (lcx) artery with 100% stenosis and was 16mm long with a reference vessel diameter of 2.75mm.Target lesion # 1 was treated with pre-dilatation and placement of a 2.50x20mm promus element plus drug-eluting stent.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2015, the patient presented due to cardiac angina and was hospitalized on the same day.Cardiac catheterization was recommended.The following day, the 99% stenosis located in distal lcx was treated with percutaneous coronary intervention (pci).The 60% stenosis located in proximal left anterior descending (lad) artery was treated with pci.The following day, the event was considered resolved and the patient was discharged on aspirin and ticagrelor.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2015, the patient presented with complaints of shortness of breath, chest tightness, radiation to both arms and neck and not angina as previously reported.Ekg showed some non-specific t-wave changes.On the following day, troponin-i was noted to be elevated and the patient was diagnosed with myocardial infarction.The 99% stenosis in the left circumflex artery (lcx) was treated with pre-dilation and placement of 3.0x23mm non-bsc stent, with 0% residual stenosis.The 60% stenosis in proximal left anterior descending artery (lad) was treated with placement of a 3.0x23mm non-bsc stent.Following post-dilation, residual stenosis was 0%.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5471747
• MDR Text Key: 39414864
• Report Number: 2134265-2016-01328
• 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,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2013
• Device Model Number: H7493911420250
• Device Catalogue Number: 39114-2025
• Device Lot Number: 15112162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2012
• 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: 59 YR