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 H7493926038350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Thrombosis (2100)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id 2134265-2018-00166.It was reported that thrombosis occurred.In (b)(6) 2017, the patient presented for percutaneous coronary intervention (pci).The target lesion was located in the left circumflex artery.A 182cm choice¿ guide wire was advanced to the lesion; however, the wire became stuck behind the stent strut.The wire was completely coated in polymer but the tip looked like a "spring coil".It was impossible to remove the detach fragment and, so it remained in the patient.The physician took ownership, and said it was not a product failure, it was just based upon where he had put it.The physician ended up stenting and tacking it up against the wall and the procedure was completed.The patient got a lot of comorbidities and had an ischemic stroke with an unknown origin.However, the patient's condition was very fair with no further patient complications reported.In (b)(6) 2018, the patient came back with either thrombosis or restenosis in the 3.50 x 38 synergy ii drug-eluting stent that covered the detach guide wire fragment.The vessel is down at this point.This time, the patient had multi-vessel disease.The patient was doing fine and stable, and was scheduled for coronary artery bypass grafting (cabg).

Manufacturer Narrative

Describe event or problem and patient codes updated.Outcomes attrib.To ae corrected from other to hospitalization and required intervention.(b)(4).

Event Description

It was further reported that in (b)(6) 2018 the patient presented in the emergency department with chest pain which led to the discovery of in-stent thrombosis.The patient needed coronary artery bypass grafting which was performed in another hospital.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7287390
• MDR Text Key: 100645304
• Report Number: 2134265-2018-01124
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2018
• Device Model Number: H7493926038350
• Device Catalogue Number: 39260-3835
• Device Lot Number: 0020340144
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR