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

Model Number	H7493911428350
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985)
Date of Event	06/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2016-12409 (b)(6) study.It was reported that in stent restenosis and angina occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.Target lesion # 1 was an ostial lesion located in the proximal portion of saphenous vein graft (svg) to obtuse marginal (om1) with 90% stenosis and was 24 mm long with a reference vessel diameter of 3.5 mm.Target lesion # 1 was treated with direct stent placement using a 3.50 x 28 mm promus element¿ plus stent, with 10% residual stenosis.Target lesion # 2 was a de novo lesion located in the distal left circumflex (lcx) with 90% stenosis and was 8 mm long with a reference vessel diameter of 2.25 mm.Target lesion # 2 was treated with pre-dilatation and placement of a 2.25 mm x 12 mm promus element¿ plus stent.Following post-dilatation, residual stenosis was 0%.Target lesion # 3 was a de novo lesion located in the left main coronary artery (lmca) with 95% stenosis and was 24 mm long with a reference vessel diameter of 2.75 mm.Target lesion # 3 was treated with pre-dilatation and placement of a 2.75 x 28 mm promus element¿ plus stent, with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, a 2.5x24mm promus element¿ plus stent was implanted in the svg to om1.In (b)(6) 2016, the patient was hospitalized due to complaints of chest pain that was subsequently diagnosed as unstable angina.The patient was referred for cardiac catheterization and revealed 100% stenosis of the proximal portion of the graft and distal portion of previously placed stents (isr) of svg to om1.The stenosis was then treated balloon angioplasty and placement of 3.5 x 38 mm non bsc des stent with 0-10% residual stenosis and the event was considered resolved.The following day, the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6226044
• Report Number: 2134265-2016-12406
• Device Sequence Number: 10775812
• Product Code: NIQ
• UDI-Device Identifier: 08714729808046
• UDI-Public: (01)08714729808046(17)20130624(10)15422861
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: 06/24/2013
• Device Model Number: H7493911428350
• Device Catalogue Number: 39114-2835
• Device Lot Number: 15422861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/05/2017
• 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: 57 YR