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

Model Number H7493941838220

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: used (b)(6) 2020 (first day of the month of bsc aware date) as the event date was not provided.

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary artery.Following pre-dilatation with a 2.0 x 30mm emerge balloon, a 2.25 x 38mm synergy xd drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and the stent was damaged.No patient complications were 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11064374
• MDR Text Key: 223403036
• Report Number: 2134265-2020-18390
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: 08714729980773
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: H7493941838220
• Device Lot Number: 0025614056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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