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

Model Number 10623

Device Problems Positioning Failure (1158); Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that stent damage occurred.The target lesion was located in the rca.This 3.00 x 38 synergy stent was selected.During advancement through a guidezilla ii guide extension catheter, the balloon became caught on the collar of the guidezilla.The distal end of the synergy stent was pierced, which led to non-deployment of the stent and longitudinal compression.The synergy stent was finally implanted, but new complex stenting was required which may have increased the risk of thrombosis the patient did not experience thrombosis and the procedure was successfully complete.No patient complications were reported.

Manufacturer Narrative

Device is combination product device evaluated by mfr:a synergy ous mr 3.00 x 38mm stent delivery system was returned for analysis without a stent.The balloon was reviewed.There was no stent on the balloon.Stent crimp markings were evident on balloon.The balloon folds were present but relaxed from the original tightly folded condition.What appeared to be contrast media solution was evident in the balloon and inflation lumen.A leak test was carried out using encore inflation device, when pressure was applied a pinhole leak was noted in the balloon material at the distal markerband site.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found tip damage.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The target lesion was located in the rca.This 3.00 x 38 synergy stent was selected.During advancement through a guidezilla ii guide extension catheter, the balloon became caught on the collar of the guidezilla.The distal end of the synergy stent was pierced, which led to non-deployment of the stent and longitudinal compression.The synergy stent was finally implanted, but new complex stenting was required which may have increased the risk of thrombosis the patient did not experience thrombosis and the procedure was successfully complete.No patient complications were reported.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8528423
• MDR Text Key: 142389411
• Report Number: 2134265-2019-04067
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023242482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention