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 H7493926020250

Device Problems Device Damaged Prior to Use (2284); Physical Resistance (2578)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2016

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 without the distal part of the device including parts of the midshaft, outer, inner , balloon, stent and tip.A visual and tactile examination of the midshaft section found the midshaft broken at 164mm distal from the hypotube to the midshaft bond.The damage most likely occurred due to excessive tensile force being applied to the delivery system.A review of the outer extrusion, inner lumen and bi-component bond could not be completed as the distal part of the device was not returned for examination.Additional information on how the distal part detached and if it was still available for analysis had been requested from the customer however no response was received.A visual and tactile examination found the corewire kinked and no other issues with the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.Distal part of the delivery catheter was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on device analysis completed on 14-dec-2016.It was reported that difficulty prepping device was encountered.During preparation of a 2.50 x 20 synergy ii drug-eluting stent, the stylet got stuck in the stent and could not be removed.The procedure was completed with another 2.50 x 20 synergy ii drug-eluting stent.No patient complications were reported.However, returned device analysis revealed shaft break.

• 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: 6237462
• MDR Text Key: 64372923
• Report Number: 2134265-2016-12201
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Physician
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2017
• Device Model Number: H7493926020250
• Device Catalogue Number: 39260-2025
• Device Lot Number: 0019075247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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