MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926220250

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.There was no issue with the hub.There were several stent struts that were stretched and bent.The stent had stretched over the distal cone of the balloon.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found no issues with the hypotube shaft profile or the shaft polymer extrusion profile.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 01-jun-2016.It was reported that hub damage occurred.A 2.50x20 synergy¿ dug-eluting stent was selected for use.During unpacking, it was noted that the hub of the stent visually seemed to be slightly crushed.No patient complications were reported.However, returned device analysis revealed stent damage.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5759468
• MDR Text Key: 48467139
• Report Number: 2134265-2016-05460
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/01/2016

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: 01/25/2017
• Device Model Number: H7493926220250
• Device Catalogue Number: 39262-2025
• Device Lot Number: 18275989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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