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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Angina (1710)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that stent under expansion and recoil of stent occurred.In (b)(6) 2017, clinical status assessment indicated the patient¿s qualifying condition as stable angina and was further referred for cardiac catheterization.Subsequently, coronary angiography and index procedure were performed.Target lesion #1 was located in the proximal right coronary artery (rca) with 75% stenosis and was 12mm long with a reference vessel diameter of 3.0mm.Target lesion #1 was treated with direct placement of a 3.00 x 20mm study stent.Following post dilatation, the residual stenosis was 5%.Target lesion #2 was located in the mid left anterior descending (lad) artery with 75% stenosis and was 30mm long with a reference vessel diameter of 2.75mm.Target lesion #2 was treated with direct placement of a 2.75 x 38mm study stent.Following post dilatation, the residual stenosis was 5%.On the same day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient visited for follow up of atherosclerotic heart disease of native coronary artery with other forms of angina pectoris.The patient reported classic chest discomfort while walking one fourth of a mile at a brisk pace, and experiences the same while biking and swimming.Since the angina resolves with rest or slowing down, no nitroglycerin was needed.The patient reported experiencing mild episodes of exertional dyspnea related to the episodes of angina with no symptoms at rest.Coronary angiography revealed patent study stents deployed during the index procedure, however per physician, there was a concern for a possibility of early stent occlusion or progression of disease proximal or distal to the stent.Alternatively, the first diagonal stenosis might be causing the angina and was treated with medical therapy.The patient continued to have symptoms.Cardiac catheterization was recommended however it was decided to treat the patient medically for 21 days to check if the symptoms persist.The patient continued to have symptoms and in (b)(6) 2018, after discussing several options with the patient, the decision was made to proceed with percutaneous coronary intervention (pci) of the left main and proximal lad in (b)(6) 2018, the patient presented for planned pci and coronary angiography was performed.Orbital atherectomy was performed for treating the calcium arc in left main.Post atherectomy, balloon angioplasty of the mid lad with 3.00 x 15mm non-bsc balloon was performed.The under expansion of the study stent implanted in mid lad was treated with balloon angioplasty using 3.5 x 15mm nc balloon, however, some degree of recoil and under expansion persisted mainly because of calcium behind the stent which was not treated during the index procedure.As the post-dilatation results were adequate, it was decided to not place an additional stent but to evaluate the response to treatment.Additionally, on the same day, 79% stenosis in left main coronary artery (lmca) extending to proximal lad was treated with 3.5 x 33mm non-bsc drug-eluting stent.Following post dilatation, the residual stenosis was 0%.The patient was recommended for a follow-up.

• 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: 7567246
• Report Number: 2134265-2018-04850
• Device Sequence Number: 11278438
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: 05/16/2018
• Device Model Number: H7493926038270
• Device Catalogue Number: 39260-3827
• Device Lot Number: 0020679526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/04/2018
• 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: 76 YR