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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Myocardial Infarction (1969); Restenosis (4576)

Event Date 10/22/2021

Event Type  Injury  

Event Description

Agent ide study: it was reported that in-stent restenosis and myocardial infarction occurred.On (b)(6) 2019, stenosis at the mid left anterior descending (lad) was treated with a 2.50 mm x 20 mm synergy stent.The proximal lad was treated with a 3.00 mm x 20 mm synergy stent.Additionally, a 2.25 mm x 20 mm unknown stent was implanted at the distal lad.On (b)(6) 2021, the subject presented to the hospital with unstable angina and was referred for the agent ide study.Coronary angiography revealed 80% - 90% in-stent restenosis at the mid and distal lad.The target lesion was 15 mm long with a reference vessel diameter of 3.0 mm.The target lesion was predilated with a 2.50 mm x 20 mm balloon and a laser catheter.The lesion was then successfully treated with a 3.00 mm x 20 mm agent dcb with 0% residual stenosis and timi flow 3.The next day, the subject was discharged home with aspirin and ticagrelor.On (b)(6) 2023, the subject began experiencing cardiac symptoms and collapsed while working.The subject was immediately taken to emergency, where the subject was noted with ventricular tachycardia cardiac arrest.At the time of the event the subject was on aspirin and ticagrelor, which was continued.At the emergency, laryngeal mask airway was placed, and the subject was defibrillated one time and achieved return of spontaneous circulation.The subject was noted with acute heart failure exacerbation.The subject was intubated, and ct chest/abdomen was performed which showed no pulmonary embolism but revealed multiple rib fractures (multiple bilateral minimally displaced rib fractures secondary to cpr and concern for aspiration.The subject was admitted to critical intensive care unit and hospitalized for further evaluation and treatment.The subject was diagnosed with non-st-elevation myocardial infarction (nstemi).The location of myocardial infarction was lateral, and mi was classified as non-q-wave mi.During the hospital stay, the subject was also noted with acute hypoxic respiratory failure.Coronary angiography revealed 50-60% in-stent restenosis at the lad.The 90% stenosed saphenous to om was successfully treated by a 4.00 mm x 20 mm synergy megatron stent.During hospital stay, the subject was noted agitated and restless.On january 2, 2023, the myocardial infarction was considered recovered/ resolved and the subject was discharged home with the advice to continue aspirin and ticagrelor.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18691616
• MDR Text Key: 335187424
• Report Number: 2124215-2024-08012
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: Black Or African American