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

Model Number 10620

Device Problems Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.A 3.50 x 24mm synergy stent delivery system was returned for analysis.Examination of the crimped stent identified distal stent damage.Stent struts at the proximal end of the stent were flared outwards and damaged.Damage was noted to the most distal stent strut row with struts lifted and pulled back distally.The undamaged crimped stent outer diameter was measured using snap gauge and was within max 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.There was no evidence of a balloon profile issue.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.Examination of the tip found damage to the tip.Device was loaded onto and tracked over a 0.014 inch guidewire without issue.An attempt was made to insert the device into a 5fr guide catheter however the device could not be inserted.The distal end of the stent met resistance which appeared to be due to the stent damage.An attempt was made to insert the device into a 6fr guide catheter, the device was inserted into and advanced through and withdrawn from the 6 fr guide catheter without issue.No other issues were identified during the product analysis.

Event Description

Reportable based on analysis completed on 30oct2019.It was reported that the balloon was already inflated prior to use.A percutaneous coronary intervention was being performed.During prep, the 3.50 x 24mm synergy ii drug-eluding stent balloon was noted to be expanded at its proximal and distal ends and could not be introduced.The procedure was successfully completed without issue or patient injury.However, returned device analysis revealed stent damage.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9345097
• MDR Text Key: 171994507
• Report Number: 2134265-2019-13689
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2019
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0021921349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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