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 H7493926016400

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059)

Event Date 06/16/2017

Event Type  Death  

Manufacturer Narrative

Device is 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 Description

Same case as mdr id: 2134265-2017-06679, 2134265-2017-06948 and 2134265-2017-06939.It was reported that vessel occlusion, myocardial infarction and death occurred.The patient presented with ostial circumflex (cx) disease.A fighter guidewire was advanced into the vessel.A 3.0x20mm synergy drug eluting stent was advanced and deployed in the left main (lm) artery into the cx.An 8f guide catheter was advanced further into the vessel and subsequently longitudinally deformed the deployed 3.0x20mm synergy stent.The deformed stent trapped the fighter guidewire in the stent structure.Subsequently the fighter guidewire fractured.The trapped portion remained in the vessel.Two synergy stents sizes 3.0x12mm and 4.0x16mm were deployed in the vessel to cover the deformed stent.The procedure ended and patient left the catheterization lab without further complication.Eight days later the patient presented to the emergency department of another hospital with an acute st segment elevation myocardial infarction (stemi).Angiography revealed the lm had closed off in the mid segment.There was no visualization of the left anterior descending (lad) or cx arteries.The type of occlusion was not stated.The surgeons were called immediately.The patient was intubated and iabp was placed.The patient was sent to surgery.The next day the patient expired.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6686147
• MDR Text Key: 79054099
• Report Number: 2134265-2017-06938
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: (01)08714729840138(17)20170808(10)0019582617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2017
• Device Model Number: H7493926016400
• Device Catalogue Number: 39260-1640
• Device Lot Number: 0019582617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 69 YR