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

Model Number H7493942832350

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

Patient Problem Perforation of Vessels (2135)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) study.It was reported that a perforation occurred.On (b)(6) 2021, the index procedure was performed.The 100% stenosed target lesion was located in the proximal right coronary artery (rca) extending to the first right posterolateral branch (1st rpl) and was 90mm long, with a reference vessel diameter of 4mm.The target lesion was predilated with 2.5mm largest balloon with maximum inflation pressure of 14mm using ivus.The lesion was treated with the placement of a 3.50 mm x 32 mm study stent.Post dilatation was performed with a 4mm balloon inflated to maximum pressure of 18mm.Timi flow was 0, with a 100% residual stenosis.A perforation was noted.However, no thrombus and abrupt closure were noted post procedure.No further complications were reported in relation to this event.On (b)(6) 2021, the subject was discharged on dual antiplatelet therapy.

• Brand Name: SYNERGY MEGATRON
• 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: 12454737
• MDR Text Key: 271013815
• Report Number: 2134265-2021-11512
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: H7493942832350
• Device Lot Number: 0026505660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR