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	H7493926008250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Intimal Dissection (1333); Angina (1710); Dyspnea (1816); Reocclusion (1985); Thrombosis (2100)
Date of Event	06/09/2017
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
Same case as mdr# 2134265-2017-08151, (b)(6) study.It was reported that in-stent restenosis and stent thrombosis occurred.In (b)(6) 2016, clinical status assessment indicated that the patient's qualifying condition as unstable angina and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 22mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with direct placement of 2.75 x 24mm and 2.50 x 8mm synergy ii study stents.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel).In (b)(6) 2017, patient presented with the chief complaints of left sided chest pain which was radiating to back and down to left arm and mild shortness breath since 2- 3 weeks.Patient had stated that he had recurrent symptoms of angina and dyspnea on exertion.Electrocardiogram (ekg) was performed on the same day and revealed sinus rhythm with no ischemic abnormalities.The patient was restarted on aspirin and was scheduled for a diagnostic cardiac catheterization.In (b)(6) 2017, coronary angiography revealed tubular focal 80% mid lad in-stent restenosis, patent- rest of the stented segment and distal lad.The following day, percutaneous coronary intervention was performed.The interventional procedure included stenting to lad and right coronary artery (rca).The 80% mid lad in-stent restenosis was treated with direct placement of 2.5 x 12mm non-bsc stent with 0% residual stenosis.The 60% stenosis in proximal and mid rca was treated with pre-dilatation and placement of 2.5 x 26mm and 2.5 x 30mm non-bsc stents.Following post dilatation residual stenosis was 0%.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that there was no evidence of stent thrombosis noted during this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the target lesion was located in the proximal left anterior descending artery (lad) extending up to mid lad.Post 2.75x24mm study stent placement, there was a clear cut hazy distal stent edge dissection for which, 2.50x8mm study stent was deployed in an overlapping manner in mid lad.In (b)(6) 2017, coronary angiography revealed tubular focal 70% in-stent restenosis of study stent in mid portion and not 80% mid lad as previously reported.

• 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: 6789596
• Report Number: 2134265-2017-08152
• Device Sequence Number: 121703
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: (01)08714729839972(17)20160930(10)0018482560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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: 09/30/2016
• Device Model Number: H7493926008250
• Device Catalogue Number: 39260-0825
• Device Lot Number: 0018482560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 10/10/2017; 02/21/2018
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/27/2017; 03/19/2018
• 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: 70 YR