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

Model Number	H7493911408250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Reocclusion (1985)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Additional 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 root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
(b)(6).It was reported that in-stent restenosis occurred.In (b)(6) 2012, the patient presented due to unstable angina.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) artery with 70% stenosis and was 6 mm long with a reference vessel diameter of 2.50 mm.The target lesion was treated with direct placement of a 2.50 x 8 mm promus element¿ plus drug eluting stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, patient presented with intermittent chest pain suggestive of unstable angina.The chest pain was associated with shortness of breath.Subsequently the patient was referred for cardiac catheterization and was hospitalized on the same day.Coronary angiography was performed and an 80% in-stent restenosis in mid lad was noted and was then treated with placement of 3.00 x 20 mm synergy¿ drug eluting stent with 0% residual stenosis.On the following day, the event was considered resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6460860
• Report Number: 2134265-2017-02711
• Device Sequence Number: 13572151
• Product Code: NIQ
• UDI-Device Identifier: 08714729807872
• UDI-Public: (01)08714729807872(17)20130730(10)15513222
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/15/2017

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: 07/30/2013
• Device Model Number: H7493911408250
• Device Catalogue Number: 39114-0825
• Device Lot Number: 15513222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/05/2017
• 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: 46 YR