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

Model Number H7493911438250

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Occlusion (1984)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis and angina occurred.In (b)(6) 2013, the patient presented with angina and st elevated myocardial infarction.Subsequently, index procedure was performed one day later.The target lesion was a de novo lesion located in the mid left anterior descending artery with 75% stenosis and was 36 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 38 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0 %.On the following day, patient was discharged on aspirin and ticagrelor.In (b)(6) 2018, the patient came for a follow-up visit with the chief complaint of worsening chest pain since last month.The patient's chest pain lasted for 5 -10 minutes with nitroglycerin, however was worst with stress and exertion.The patient's chest pain with an accelerating pattern, concerned for canadian class 4 angina and the patient was scheduled for left heart catheterization in three days.In (b)(6) 2018, the patient was sent for left heart catheterization which revealed in-stent restenosis (isr) in the 60%-70% range proximally and 30% stenosis in the distal aspect of the stent.The 60-70% isr was treated with balloon angioplasty with 10% residual stenosis and timi 3 flow.On the following day, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the angina was not related to this device and the in-stent restenosis referred to a non-bsc drug-eluting stent deployed in the proximal left anterior descending (lad) artery.Also, there was no stenosis in mid lad.

• 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: 7348685
• MDR Text Key: 102739889
• Report Number: 2134265-2018-01986
• 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: 02/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2013
• Device Model Number: H7493911438250
• Device Catalogue Number: 39114-3825
• Device Lot Number: 15794626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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: 59 YR