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 H7493926024300

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.A 3.00 x 24 synergy ii drug eluting stent was selected to treat the lesion.However, during unpacking, it was noticed that the stent strut was flared out.The device was not used and the procedure was completed with a different device.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system was returned for analysis.A visual examination of the crimped stent found proximal stent damage with proximal struts 1 and 2 lifted and pulled distally overlapping strut 3.The distal and center part of the stent showed no signs of damage.The crimped stent outer diameter (od) on the undamaged side was measured and is within specification.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip of the device showed no signs of damage.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found no issues.The inner lumen and bi-component bond showed no signs of damage or strain.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.A 3.00 x 24 synergy ii drug eluting stent was selected to treat the lesion.However, during unpacking, it was noticed that the stent strut was flared out.The device was not used and the procedure was completed with a different device.

• 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: 6189170
• MDR Text Key: 62851010
• Report Number: 2134265-2016-11842
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: (01)08714729840237(17)20170824(10)19660585.
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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: 08/24/2017
• Device Model Number: H7493926024300
• Device Catalogue Number: 39260-2430
• Device Lot Number: 19660585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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