MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926038250

Device Problems Stretched (1601); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.During preparation of a 2.50 x 38mm synergy¿ drug-eluting stent, the stent was stuck on the stent protector and stretched off the balloon delivery system.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Synergy ii, us, mr, 2.5 x 20mm stent delivery system (sds); was returned for analysis.A visual examination of the crimped stent found that the stent had detached and separated from the delivery system.The struts were stretched and distorted.The balloon cones were reviewed and no issues were noted.Crimp markings were evident on the balloon wall indicating overall crimp contact between the coated stent and balloon.The product stent protector was returned for analysis with the device, the id was within specification.Based on the specified stent protector profile and the maximum crimped stent profile for this device shows there is no issues to note with the interaction between the two components.A visual and tactile examination found multiple kinks on the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.The bumper tip of the device showed no signs of damage.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that stent damage occurred.During preparation of a 2.50 x 38mm synergy¿ drug-eluting stent, the stent was stuck on the stent protector and stretched off the balloon delivery system.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6132818
• MDR Text Key: 61091001
• Report Number: 2134265-2016-10870
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: (01)08714729840398(17)20170707(10)19476406
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: H7493926038250
• Device Catalogue Number: 39260-3825
• Device Lot Number: 19476406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2016
• 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