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

Model Number H7493926216400

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr.: synergy ous mr 4.00 x 16mm stent delivery system was returned for analysis.An examination of the crimped stent revealed proximal stent damage.Proximal struts 1- 5 were damage with struts lifted and pulled in a distal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was within the specification.The balloon cones were reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded.A visual and tactile examination of the hypotube revealed multiple kinks.An examination of the shaft polymer extrusion found no issues.There were no signs of damage or strain to the port bond.The tip was visually examined and damage was noted.No other issues were identified during the product 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

It was reported that stent damage occurred.The 85% stenosed target lesion was located in the severely tortuous and moderately calcified left main trunk of the coronary artery.A 4.00 x 16 synergy¿ stent was advanced but it failed to cross the tortuous part in the area before reaching the lesion.Pre-dilatation was performed several times and the physician re-inserted the device but it still failed to cross.It was further reported that the stent damaged occurred during the second insertion.No replacement device was available and the procedure was completed with plain old balloon angioplasty.No patient complications were reported and the patient's status was good.

• 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: 7664278
• MDR Text Key: 113285418
• Report Number: 2134265-2018-05861
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: H7493926216400
• Device Catalogue Number: 39262-1640
• Device Lot Number: 21070597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2017
• 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