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

Model Number H7493925120250

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Death (1802); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 12/26/2016

Event Type  Death  

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 med watch will be filed.(b)(4).

Event Description

It was reported that acute stent thrombosis occurred and the patient died.The patient presented with acute myocardial infarction (mi).The target lesion was located in the left anterior descending and obtuse marginal artery.A 20 x 2.50 promus premier¿ was deployed to treat the lesion.Seven days post procedure, the patient presented with electrocardiogram changes and cardiogenic shock.In-stent thrombosis was noted at the obtuse marginal.Two drug eluting stents were implanted to treat the thrombosis.Plavix 75 mg and aspirin 80 mg were also given orally.However, it was noted that the patient died.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient presented with a non st-elevation myocardial infarction (stemi).One stent was implanted in the left anterior descending (lad) and two stents were implanted in the left circumflex (lcx) artery.Two days post procedure, the patient presented with chest pain and high st in posterior leads.Coronary angiography showed stent thrombosis in both lcx stents.Aspiration thrombectomy and balloon with another stents in lcx artery were performed.Subsequently, the patient was transferred to cardio care unit (ccu) but was unstable and died despite cardiopulmonary resuscitation (cpr).

• Brand Name: PROMUS PREMIER¿
• 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: 6264640
• MDR Text Key: 65302536
• Report Number: 2134265-2017-00457
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: 02/18/2017
• Device Model Number: H7493925120250
• Device Catalogue Number: 39251-2025
• Device Lot Number: 18359426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 69 YR