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

Model Number	H7493911412250
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that patient experienced unstable angina and in-stent restenosis occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina.Prior to procedure, the patient was indicative of ischemia and the patient was referred for elective cardiac catheterization.Subsequently, coronary angiography and the index procedure were performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 8mm long with a reference vessel diameter of 2.5mm.Target lesion was treated with pre-dilatation and placement of a 2.50x12mm study stent.Following post- dilation, the residual stenosis was 0%.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented with complaints of chest pain.The patient was recommended for a cardiac catheterization on a later date and was advised to take sublingual nitroglycerin in case of recurrent acute chest pain.Three days after, the patient presented for the evaluation of chest pain and was hospitalized on the same day.The 70-80% tubular stenosis in mid lad and 80% in-stent restenosis in proximal first diagonal was treated with pre-dilation and placement of 3.0 x 12mm and 2.50 x 20mm synergy stents respectively.Following post dilation, residual stenosis was 0%.Follow-up core-lab angiography findings of mid lad, noted absence of thrombus as well as aneurysm.However core lab noted presence of in-stent restenosis (isr) pattern 1b.Revascularization included target lesion revascularization (tlr) and remote target vessel revascularization (tvr).On the next day, the patient was discharged on dual antiplatelet therapy.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7726672
• Report Number: 2134265-2018-06762
• Device Sequence Number: 1015572
• Product Code: NIQ
• UDI-Device Identifier: 08714729807827
• UDI-Public: 08714729807827
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/06/2018

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: 09/09/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15609951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/27/2018
• 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: 71 YR