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

Model Number 10607

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that packaging issue was encountered.During preparation of a synergy stent, the labeling on the box indicated the device contained to be a 3.00x32mm synergy; however, the device inside was a 3.00x38mm synergy.The procedure was completed with a different device.There was no serious injury or adverse patient effect.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: a sealed synergy ii us mr 3.00 x 38 mm inner tyvek pouch was returned for analysis.No damage was noted and all labelling legible.A label had been removed from the front of the pouch.The stent delivery system (sds) and hoop were present in the pouch.The device details were consistent with the documented details on the label on the tyvek pouch.A visual examination of the stent found no issues.The crimped stent length was measured and the result was within crimped stent length specification for synergy 3.00x38mm.

Event Description

It was reported that packaging issue was encountered.During preparation of a synergy stent, the labeling on the box indicated the device contained to be a 3.00x32mm synergy; however, the device inside was a 3.00x38mm synergy.The procedure was completed with a different device.There was no serious injury or adverse patient effect.

• 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: 8151103
• MDR Text Key: 130048788
• Report Number: 2134265-2018-63785
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022498650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1