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

Model Number H7493926224300

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: a synergy ous mr 3.00 x 24mm stent delivery system (sds) was returned for analysis.An examination of the crimped stent revealed damage.Strut segments 6 and 7 from the distal end of the stent were damaged with struts lifted and pulled distally.The undamaged crimped stent outer diameter (od) was measured and is 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 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 14-may-2018.It was reported that crossing difficulties and shaft kinked were encountered.The 100% stenosed target lesion was located in a mildly tortuous and moderately calcified coronary artery.A 3.00 x 24mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, it was noted that the shaft was kinked.The procedure was completed with another synergy stent.No patient complications were reported and the 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: 7574759
• MDR Text Key: 110276685
• Report Number: 2134265-2018-04856
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2019
• Device Model Number: H7493926224300
• Device Catalogue Number: 39262-2430
• Device Lot Number: 0021565145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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