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

Model Number H7493911408300

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

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144); Dizziness (2194); Loss Of Pulse (2562)

Event Date 09/26/2016

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-10313.(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2012, clinical status assessment indicated that the patient's qualifying condition was unstable angina and myocardial infarction.Subsequently, the index procedure was performed.Target lesion #1 was a de novo lesion located in the prox left anterior descending (lad) artery with 90% stenosis and was 5 mm long with a reference vessel diameter of 3.2 mm.Target lesion #1 was treated with direct placement of a 3.00 mm x 12 mm promus element" plus stent with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the ramus with 85% stenosis and was 3 mm long with a reference vessel diameter of 3.00 mm.Target lesion #2 was treated with direct placement of a 3.00 mm x 8 mm promus element" plus stent with residual stenosis of 0%.On the next day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient died.The immediate cause of death was acute myocardial infarction.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient presented with shortness of breath, dizziness and abdominal pain on the left.The patient also had nausea and vomiting.The patient went into cardiac arrest and had pulseless electrical activity (pea) on the monitor.The resuscitation was not successful in the ambulance or in the emergency room.It was suspected that the cause of death could also be ruptured abdominal aortic aneurysm.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6097122
• MDR Text Key: 59713828
• Report Number: 2134265-2016-10314
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2013
• Device Model Number: H7493911408300
• Device Catalogue Number: 39114-0830
• Device Lot Number: 15288314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• 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: 82 YR