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

Model Number H7493941812400

Device Problems Material Rupture (1546); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  Injury  

Event Description

It was reported that balloon rupture and inadequate or insufficient apposition occurred.The 99% stenosed, target lesion was located in a severely tortuous and severely calcified obuse marginal branch segment/ left cirmuflex artery.The vessel was prepared with multiple balloons and a guidezilla guide extension catheter was needed to facilitate balloon and stent delivery.A 4.00x12mm synergy xd drug-eluting stent was deployed for treatment.However, during the initial inflation prior to reaching nominal pressure the balloon ruptured.It was noted that the balloon did not expand beyond the edges.The balloon was removed but the stent was severely underexpanded.After multiple attempts, 2.0 up to 4.0 balloons were used to fully inflate the stent and ensure adequate expansion.The patient was treated successfully with multiple stents back to the left main and the procedure was completed.No patient complications nor injuries reported.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11558358
• MDR Text Key: 241931249
• Report Number: 2134265-2021-03054
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: H7493941812400
• Device Lot Number: 0026547433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• 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