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

Model Number H7493911420300

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hypoxia (1918)

Event Date 09/06/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

(b)(6) clinical study.Same case as mfr report#: 2134265-2018-00107.It was reported that post a coronary artery drug eluting stenting treatment procedure, the patient had cardiac arrest and expired.In (b)(6) 2013, the patient presented due to unstable angina (braunwald classification: iiib) and myocardial infarction and was referred for cardiac catheterization.The first target lesion was a de novo lesion located in the 1st obtuse marginal branch (om1) with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation and placement of a 2.50 x 28 mm promus element plus stent, with 0% residual stenosis and timi 3 flow.The second target lesion was a bifurcated de novo lesion located in the left main coronary artery (lmca) with 60% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.It was treated with pre-dilatation and placement of a 3.00 x 20 mm promus element plus stent.Following post dilatation, residual stenosis was 0% and timi 3 flow.The patient was discharged on aspirin and clopidogrel the next day.In (b)(6) 2017, the patient was hospitalized due to cardiac arrest.The patient expired four days later and the cause of death was cardiac arrest.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient had expired due to cardiac arrest bought on by respiratory arrest and hypoxia.

• 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: 7221264
• MDR Text Key: 98306521
• Report Number: 2134265-2018-00108
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 0015706972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• 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: 66 YR