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

Model Number	H7493911428250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100); Ventricular Fibrillation (2130)
Date of Event	04/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not received 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
Same case as mdr id: 2134265-2017-03284 and 2134265-2017-03285.(b)(6) study.It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented due to unstable angina.Subsequently, cardiac catheterization was recommended.The target lesion was a de novo lesion located in the proximal left anterior descending (lad) with 90% stenosis and was 26 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50x28mm promus element¿ plus stent.Following post-dilatation, residual stenosis was 0% with timi 3 flow.On the following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient presented to the emergency department after an episode of persistent chest pain and ventricular fibrillation arrest and reported an event of st elevation myocardial infarction (stemi).The patient was further referred for cardiac catheterization.The 100% in-stent restenosis in proximal lad was treated with balloon angioplasty and placement of a 12x3.50mm synergy¿ stent with 0% residual stenosis with timi 3 flow.Following the procedure the patient started to experience some chest pain.He was re-catheterized and was found to have acute stent thrombosis of the 12x3.50mm synergy¿ stent.Stent thrombosis thought to be due to being unable to take ticagrelor until after the procedure.A repeat percutaneous intervention was performed with placement of 2.75 x 12 mm synergy drug-eluting stent proximal to the 2.50x28mm promus element¿ plus stent.Post procedural stenosis was 0% with timi 3 flow.The patient also had successful intra-aortic balloon pump placement to increase coronary reperfusion during the procedure and to decrease the risk for further in-stent thrombosis.He was on heparin drip along with the intra aortic balloon pump.Echocardiogram showed mildly reduced ejection fraction of 44% with lad wall motion abnormality.The patient had paroxysmal episodes of atrial fibrillation while he was in the hospital.He did well after his repeat percutaneous intervention.Two days after, the balloon pump was able to be removed.The patient ambulated well with physical therapy, and denied any further complaints of chest pain.He remained hemodynamically stable.Four days post-procedure, the patient was discharged home in stable condition on triple therapy with aspirin, plavix, and pradaxa.It was recommended that his aspirin be discontinued after 30 days after stent placement and continued plavix and pradaxa for at least 1 year.The event was considered resolved.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that per source document thrombotic occlusion of proximal lad was noted.The site confirmed that there was acute stent thrombosis of 3.5 x 12 mm non-study synergy stent only and there was no stent thrombosis noted for the study stent placed in proximal lad.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that stent thrombosis occurred as per adjudication results.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6442301
• Report Number: 2134265-2017-02430
• Device Sequence Number: 681931
• Product Code: NIQ
• UDI-Device Identifier: 08714729807865
• UDI-Public: (01)08714729807865(17)20130910(10)15609357
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 03/06/2017

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: 09/10/2013
• Device Model Number: H7493911428250
• Device Catalogue Number: 39114-2825
• Device Lot Number: 15609357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided; 07/25/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/28/2017; 08/09/2017
• 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