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

Model Number H7493911408250

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 03/24/2017

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

Promus element plus clinical study.It was reported that angina and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented due to stable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was a de novo lesion located from distal saphenous vein graft (svg) to 1st diagonal branch with 70% stenosis and was a 4 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 8 mm pe plus stent 0% residual stenosis.Target lesion #2 was a de novo lesion located from proximal svg to 1 st diagonal with 90% stenosis and was a 14 mm long with a reference vessel diameter of 3.0 mm.Target lesion #2 was treated with direct placement of a 3.00 x 16 mm pe plus stent with 0% residual stenosis.The next day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented with worsening symptoms of stable angina.The patient experienced symptoms of angina with very little activity for the past few weeks.Cardiac catheterization was recommended.In (b)(6) 2017, cardiac catheterization revealed a 99% stenosis and 50% isr of study stent located at distal portion of svg to 1st diagonal branch and was treated with predilatation and placement of 2.5 x 18 mm and 3.0 x 12 mm non-bsc stents in an overlapping fashion.Following post dilatation, there was 0% residual stenosis and timi 3 flow.A day after, the event was considered to be resolved and the patient was discharged from the hospital.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7278256
• MDR Text Key: 100317349
• Report Number: 2134265-2018-01032
• 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: 01/25/2018

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: 12/16/2013
• Device Model Number: H7493911408250
• Device Catalogue Number: 39114-0825
• Device Lot Number: 15805404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2013
• 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: 66 YR