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

Model Number	H7493911432250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985)
Date of Event	12/21/2016
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
(b)(6).It was reported that stent restenosis and angina occurred.In (b)(6) 2012, the patient presented due to unstable angina and was diagnosed with myocardial infarction(mi).Subsequently, patient was referred for cardiac catheterization.On the same day, index procedure was performed.Target lesion # 1 was a de novo lesion located in the mid right coronary artery(rca) with 80% stenosis and was 16mm long with a reference vessel diameter of 2.50mm.Target lesion # 1 was treated with pre-dilatation and placement of a 2.50x32.00mm promus element plus drug-eluting stent(des).Following post dilatation, the residual stenosis was 0%.Target lesion # 2 was a de novo lesion located in the proximal rca with 80% stenosis and was 8mm long with a reference vessel diameter of 2.50mm.Target lesion # 2 was treated with direct placement of a 2.50x12.00mm promus element plus des.Following post dilatation, the residual stenosis was 0%.Two days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was diagnosed with unstable angina and cardiac catheterization was recommended.The 80% in-stent restenosis(isr) located in mid rca was treated with balloon angioplasty and placement of 3.00x16mm synergy des.Following post-dilatation residual stenosis was 0%.Additionally, 75% de-novo stenosis located in distal rca was treated with balloon angioplasty and placement of 2.50x12mm and 2.25x12mm synergy des with 0% residual stenosis.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6255936
• Report Number: 2134265-2016-12632
• Device Sequence Number: 13701459
• Product Code: NIQ
• UDI-Device Identifier: 08714729823681
• UDI-Public: (01)08714729823681(17)20130225(10)15144718
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/22/2016

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: 02/25/2013
• Device Model Number: H7493911432250
• Device Catalogue Number: 39114-3225
• Device Lot Number: 15144718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/17/2017
• 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: Required Intervention
• Patient Age: 69 YR