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

Model Number H7493941848250

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problems Arrhythmia (1721); Thrombosis/Thrombus (4440)

Event Date 02/17/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(6).

• Brand Name: SYNERGY XD
• Type of Device: 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
• MDR Text Key: 286558014
• Report Number: 2134265-2022-02383
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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; Other