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

Model Number H7493926238250

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

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: a synergy ous mr 2.50 x 38mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found severe stent damage.Stent strut rows 1-11 from the distal end of the stent were undamaged; the remainder of the struts were damaged and bunched in a distal direction.The outer diameter of the undamaged section of the crimped stent was measured and was within the 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 hypotube found no issues.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no signs of damage were noted.The product stent protector was not returned for analysis with the device.There are no issues to note with the interaction between the two components.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

Reportable based on device analysis completed on 31-may-2017.It was reported that tip damage occurred.A 2.50 x 38 synergy¿ drug-eluting stent was selected for use.However upon removal of the stent protector, the tip was damaged.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6641988
• MDR Text Key: 77626017
• Report Number: 2134265-2017-05981
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: SIMILAR
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: H7493926238250
• Device Catalogue Number: 39262-3825
• Device Lot Number: 0019606087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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