MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926038270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.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
It was reported that acute stent thrombosis and chest pain occurred.The target lesion was located in the left anterior descending artery (lad).After predilation, a 2.75 x 38 synergy ii drug-eluting stent was implanted and post dilation was done.However, the patient had chest pain.About 45 minutes later, it was noted that the lad was occluded.A non-bsc aspiration catheter was used to aspirate the thrombus and the patient was given integrillin and was transferred.No further complications were reported and the patient's status was fine.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6490116
• Report Number: 2134265-2017-03640
• Device Sequence Number: 86921
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: (01)08714729840404(17)20171206(10)20082751
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2017
• Device Model Number: H7493926038270
• Device Catalogue Number: 39260-3827
• Device Lot Number: 20082751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/13/2017
• 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