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

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that a markerband issue was encountered.The synergy otw stent was deployed to treat the target lesion.However, the physician stated that the 90cm and 100cm markers on the shaft of the synergy otw stent have been switched in their position.There were no patient complications.

Manufacturer Narrative

B3 date of event: used the first date of the month of the aware date as no event date was provided.The device was not returned, however a photo of the device was received attached to the complaint record.A review of the photo confirmed the alleged complaint as the 100 cm and 90 cm white hot stamp markers on the shaft are noted to be switched in position (2 markers located at the 90 cm instead of 1 and 1 marker located at 100 cm instead of 2.

Event Description

It was reported that a markerband isue was encountered.The synergy otw stent was deployed to treat the target lesion.However, the physician stated that the 90cm and 100cm markers on the shaft of the synergy otw stent have been switched in their position.There were no patient complications.

• 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
• MDR Report Key: 12526505
• MDR Text Key: 273131124
• Report Number: 2134265-2021-11654
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1