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

Model Number 10623

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified coronary artery.A 2.50 x 38mm synergy ii drug eluting stent was advanced for treatment but could not cross the lesion.After multiple attempts, the device was not deployed.However, upon removal, it was noticed that the stent was damaged.It was noted that the stent crossing difficulties lead to increase procedural time.There were no patient complication or injury to the vessel.The patient current status is fine.

• Brand Name: SYNERGY
• 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: 10555618
• MDR Text Key: 207590846
• Report Number: 2134265-2020-12983
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024909724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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