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

Model Number	H7493911420300
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.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 or Problem Description
(b)(4) clinical study.It was reported that post a coronary artery drug eluting stenting treatment procedure, in-stent restenosis occurred and the patient had angina.In (b)(6) 2013, clinical status assessment identified that the patient¿s qualifying condition as stable angina (ccs classification 2).Prior to procedure, the patient was noted to have abnormal stress test or imaging stress test indicative of ischemia and the patient was referred for elective cardiac catheterization.The target lesion was located in the 1st obtuse marginal branch (om1) with 95% stenosis and was 15 mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and placement of a 3.0 x 20 mm study stent with 0% residual stenosis.The patient was discharged on dual antiplatelet therapy the next day.In (b)(6) 2017, the patient presented to hospital with the complaints of chest pain and had stress test done.The patient was diagnosed with unstable angina.Subsequently, the subject was hospitalized and was referred for cardiac catheterization.The 95% in-stent restenosis of study stent deployed in om1 and 90% stenosis in proximal om was noted and treated with placement of 3mm non-bsc stent and 3x22mm non-bsc stent respectively following which the residual stenosis was 0% with timi 3 flow.The patient was discharged on dual antiplatelet therapy the next day.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7215874
• Report Number: 2134265-2018-00104
• Device Sequence Number: 143326
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2018

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: 07/29/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 15511519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/24/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR