MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10603

Device Problem Material Deformation (2976)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event date was not reported therefore the notification date to boston scientific was populated.

Event Description

It was reported that stent damage occurred.A 4.00 x 20 synergy ii drug-eluting stent was advanced for use but failed to cross the lesion.However, after the attempt to cross the lesion, the stent was damaged.No further information was provided.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 11016219
• MDR Text Key: 221826912
• Report Number: 2134265-2020-17901
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023791812
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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