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

Model Number H7493911424250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/01/2016

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 medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-12137, 2134265-2016-12138, 2134265-2016-12140 promus element plus clinical study.It was reported that the patient died.In (b)(6) 2012, the patient presented with unstable angina and was diagnosed with non-st segment elevation myocardial infarction (nstemi).The patient was referred for cardiac catheterization.Subsequently, the index procedure and coronary angiography were performed.Target lesion # 1 was located in the 1st diagonal with 90% stenosis and was 22mm long with a reference vessel diameter of 2.5mm.Target lesion # 1 was treated with pre-dilatation and placement of a 2.50x24am promus element plus study stent.Following post dilatation, residual stenosis was 0%.Target lesion # 2 was located in the 1st obtuse marginal with 99% stenosis and was 23mm long with a reference vessel diameter of 2.5mm.Target lesion # 2 was treated with pre-dilatation and placement of 2.75 x 8mm and 2.50 x 24mm promus element plus study stents in overlapping fashion.Following post dilatation, residual stenosis was 0%.Target lesion # 3 was located in the distal right coronary artery (rca) with 99% stenosis and was 22mm long with a reference vessel diameter of 2.75mm.Target lesion # 3 was treated with pre-dilatation and placement of a 2.75 x 24mm promus element plus study stent.Following post dilatation, residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient expired and the cause of death was unknown.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that the patient had acute myelogenous leukemia and expired on the same day.Per death certificate, the patient died due to acute myelogenous leukemia.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: 6185041
• MDR Text Key: 62699374
• Report Number: 2134265-2016-12139
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2013
• Device Model Number: H7493911424250
• Device Catalogue Number: 39114-2425
• Device Lot Number: 15117767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• 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: 76 YR