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

Model Number H7493926228400

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).  device evaluated by mfr.: stent delivery system (sds) was returned for analysis.A visual examination found that the stent was returned detached from the (sds) and severely damaged and bunched its entire length.The maximum crimped stent profile measurement at the time of manufacture was within specification.The balloon cones were reviewed and no issues were noted.The balloon did not appear to have been subjected to positive pressure.Stent crimp markings were present on the balloon body.The balloon was inflated successfully to rated burst pressure using an encore inflation device.The balloon deflated in 4 seconds and this is within measurement.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive for being applied to the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the polymer extrusion.The device was loaded on a 0.014¿¿ guide wire and no resistance was noted.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable after device analysis completed on 14-dec-2017.It was reported that the device was defective.During preparation of a 4.00x28mm synergy¿ drug-eluting stent, it was noted that the device was defective.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage and stent detached/separated.

• 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: 7175974
• MDR Text Key: 96825938
• Report Number: 2134265-2017-12924
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2018
• Device Model Number: H7493926228400
• Device Catalogue Number: 39262-2840
• Device Lot Number: 0019518409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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