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

Model Number	10604
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100); Vascular Dissection (3160)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that vessel dissection and acute thrombosis occurred and patient experienced chest pain.The patient presented with st-elevation myocardial infarction.The target lesion was located in the mid right coronary artery (rca).A 3.00 x 24 synergy drug-eluting stent was deployed in the blockage at 16 atmospheres and was post dilated with a 3.5x12 nc quantum apex to 16 atm.Another stent was also placed in the left anterior descending artery.Approximately 30 minutes after the patient went to recovery, the patient began having severe chest pain and was returned to the cath lab.It was found that the rca stent was occluded.The stent was wired with a choice pt extra support and a 3.0x12 nc quantum apex balloon catheter was used to reopen the artery.Angiojet was used to remove clot from stent and distal artery and a non-bsc intravascular ultrasound (ivus) was used to interrogate the stent.A small dissection was noted on ivus at the very proximal end of the stent.A 3.5x8 synergy was placed in an overlapping fashion to the 3.0x24 synergy and both stents were post dilated with a 3.5x8 nc quantum balloon catheter.The stent was viewed again through ivus to confirm apposition, expansion and lack of dissection.The patient was never shocked and is now pain free.

• 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: 9728646
• Report Number: 2134265-2020-01664
• Device Sequence Number: 16689233
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: 07/21/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024187151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/19/2020
• 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: Hospitalization; Required Intervention