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

Model Number H7493911416250

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 11/10/2017

Event Type  Death  

Manufacturer Narrative

Complainant name: (b)(6) medical center.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

(b)(6) clinical study.It was reported that very late stent thrombosis occurred and the patient died.In (b)(6) 2013, the patient was diagnosed with stable angina and the patient was referred for cardiac catheterization.Target lesion# 1 was a de novo lesion located in the left atrioventricular valve with 80% stenosis and was 10 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 16 mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidgrel.In (b)(6) 2017, stent thrombosis occurred and the patient died the same day.Per death certificate, the patient expired due to atherosclerotic cardiovascular disease.It was confirmed that an autopsy was not performed.

• 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: 7477060
• MDR Text Key: 107024742
• Report Number: 2134265-2018-03654
• 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: 04/09/2018

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: 09/27/2013
• Device Model Number: H7493911416250
• Device Catalogue Number: 39114-1625
• Device Lot Number: 0015664564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2012
• 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): Death
• Patient Age: 77 YR