MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941848250
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Arrhythmia (1721); Thrombosis/Thrombus (4440)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fracture and stent thrombosis occurred; patient experienced arrhythmia.The patient presented with chest pain through emergency room.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery, disease in middle and distal, proximal circumflex (cx), and chronic totally occluded obtuse marginal of cx.Right coronary artery was patent with distal focal lesion which also gave collateral to left anterior descending artery (lad).The physician placed 2.50 x 48mm synergy xd stents in proximal, mid, and distal lad and completed the procedure.The patient came back within a two-hour window for stent thrombosis (st) in proximal lad, was occluded.The 48mm synergy stent was also fractured at proximal portion and the patient experienced arrhythmia.The physician then ballooned the proximal, mid, and distal lad.Went in with non-boston scientific catheter, patient coded while in room and on table during procedure.The patient was started on aggrestat for clot.Angiomax was going prior to interventional wire being introduced.Ended up using a 2.50 x 48 stent in between the mid and distal stents to cover.No further patient complications reported.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13664849
• Report Number: 2134265-2022-02383
• Device Sequence Number: 5474782
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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: 08/25/2022
• Device Model Number: H7493941848250
• Device Lot Number: 0025974587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown