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	H7493926038220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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# 2134265-2017-07853.(b)(6) clinical study.It was reported that shaft break occurred.In (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as silent ischemia and the index procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 95% stenosis and was 20.0mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 32mm study stent.Following post-dilatation, residual stenosis was 5%.Subsequently, a 2.50 x 38 synergy ii drug-eluting stent was attempted to be implanted in an unknown lesion.However, due to broken stent shaft on a portion that was outside of the patient's body, the device was removed and was not deployed.A second 2.25 x 38 synergy ii drug-eluting stent as also attempted to be implanted in an unknown lesion.However, due to broken stent shaft on a portion that was outside of the patient's body, the device was removed and was not deployed.There were no patient complications reported and two days later, the patient was discharged on dual antiplatelet therapy.

• 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: 6758125
• Report Number: 2134265-2017-07854
• Device Sequence Number: 19185502
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: (01)08714729840381(17)20180207(10)20291669
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2018
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 20291669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR