MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10606
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent thrombosis and st-segment elevation occurred.The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line.The target lesions were located in the proximal left anterior descending artery and mid circumflex artery.Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase.However, electrocardiogram showed st-segment elevation 5 hours after stent placement.The patient was sent back to lab and it was noted that both stents were occluded.The clot was removed, stents were placed and patient was given an integrilin and brilinta.Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge.Follow-up clinic visit stated that patient is wearing a lifevest.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent thrombosis and st-segment elevation occurred.The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line.The target lesions were located in the proximal left anterior descending artery and mid circumflex artery.Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase.However, electrocardiogram showed st-segment elevation 5 hours after stent placement.The patient was sent back to lab and it was noted that both stents were occluded.The clot was removed, stents were placed and patient was given an integrilin and brilinta.Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge.Follow-up clinic visit stated that patient is wearing a lifevest.It was further reported that the patient also experienced chest pain post stent placement.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8749202
• Report Number: 2134265-2019-07037
• Device Sequence Number: 19254880
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 12/02/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023082410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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