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

Model Number H7493926216300

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Synergy mr, ous, 3.0 x 16mm, stent delivery system was returned for analysis.A visual examination of the crimped stent found stent struts around the mid-section stent moving towards the distal section were damaged.Stent appeared bent with stent struts slightly opening.The undamaged stent outer diameter was measured which is within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.A visual examination of the balloon cones was performed 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 found no issue with the hypotube.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found damage to the tip.The type of damage evident is consistent with resistance being encountered during advancement.No other damage noted during analysis.The investigation conclusion is operational context as the product meets the design & 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 11-dec-2017.It was reported that crossing difficulties were encountered.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery.Following pre-dilation, a 3.00 16mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, the device was unable to cross the lesion due to calcification and angulation.The procedure was completed with another with the same device.No patient complications were reported and patient's status was good.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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7151353
• MDR Text Key: 96117087
• Report Number: 2134265-2017-12650
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Model Number: H7493926216300
• Device Catalogue Number: 39262-1630
• Device Lot Number: 19881612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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
• Patient Age: 68 YR