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

Model Number H7493911424300

Device Problem Occlusion Within Device (1423)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100); Vomiting (2144); Diaphoresis (2452); Chest Tightness/Pressure (2463)

Event Date 12/30/2015

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: 2134265-2016-11885.(b)(6) study.It was reported that myocardial infarction and in-stent restenosis occurred.In (b)(6) 2012, the patient presented with myocardial infarction (mi) and unstable angina and subsequently, cardiac catheterization was recommended.Two days after, index procedure was performed.Target lesion #1 was a de novo bifurcated lesion located in the mid left anterior descending (lad) artery with 99% stenosis and was 16mm long with a reference vessel diameter of 3.0mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00mmx24mm promus element¿ plus drug-eluting stent, with 0 % residual stenosis.Target lesion #2 was a de novo lesion located in the proximal left circumflex (lcx) artery with 99% stenosis and was 14mm long with a reference vessel diameter of 3.0mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00x20mm promus element¿ plus drug-eluting stent, with 0% residual stenosis.Three days after, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient presented to emergency department with the complaints of sub sternal chest pressure, nausea, vomiting, shortness of breath and diaphoresis.On the same day, 100% in-stent restenosis (isr) of study stent located in proximal lcx was attempted with aspiration thrombectomy, however a non-bsc catheter was difficult to pass into the old stent area.Then the lesion was treated with placement of 3.5x16mm promus premier drug-eluting stent.Following post dilatation, the residual stenosis was 0% and there was timi flow 3.Additionally, the100% isr of study stent located in mid lad was attempted with aspiration thrombectomy, however the non-bsc catheter was difficult to pass into the old stent area.Then the lesion was treated with placement of 3.5x16mm promus premier drug-eluting stent with 0% residual stenosis and timi flow 2.Later, intra aortic balloon pump (iabp) was inserted and pumping was performed which resulted timi flow 3.Three days after, the event was considered as resolved and the patient was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that stent thrombosis of the 3.00mmx24mm and 3.00x20mm promus element¿ plus stents occurred and not in-stent restenosis as previously reported.

• 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: 6181818
• MDR Text Key: 62605385
• Report Number: 2134265-2016-11884
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2013
• Device Model Number: H7493911424300
• Device Catalogue Number: 39114-2430
• Device Lot Number: 15409717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2012
• 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): Required Intervention
• Patient Age: 56 YR