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 H7493926024250

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).A synergy ii us mr 2.50 x 24mm stent delivery system was returned for analysis.A visual examination of the crimped stent found no issues.There were no signs of damage, lifting or stretching of the stent struts.The crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.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.A visual and tactile examination of the device found multiple kinks along the full catheter length.The hypotube was broken at approximately 787mm distal to the distal end of the strain relief.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and no issues were noted.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/ procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 29-nov-2017.It was reported that crossing difficulties were encountered.A 2.50 x 24mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube 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: 7136091
• MDR Text Key: 95669389
• Report Number: 2134265-2017-12294
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2018
• Device Model Number: H7493926024250
• Device Catalogue Number: 39260-2425
• Device Lot Number: 0020815965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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