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

Model Number	9323
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	06/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the clinical status assessment indicated that the patient's qualifying condition was stable angina.Prior to procedure, the patient was found to have evidences of ischemia and the patient was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion# 1 was located in the first obtuse marginal branch segment with 90% stenosis and was 15mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00x12mm study stent.Following post dilatation, residual stenosis was 5%.One day post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient suddenly felt sick and collapsed.In (b)(6) 2018, during the follow-up, the patient's relative was contacted and was informed about the patient's sudden death.The cause of death was unknown and it was unknown if the autopsy was performed or not.The adjudication indicated possible stent thrombosis.

• Brand Name: PROMUS ELEMENT PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8132750
• Report Number: 2134265-2018-63513
• Device Sequence Number: 11328058
• Product Code: NIQ
• UDI-Device Identifier: 08714729807940
• UDI-Public: 8714729807940
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2013
• Device Model Number: 9323
• Device Catalogue Number: 9323
• Device Lot Number: 15597831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR