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

Model Number H7493926228250

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that a foreign matter was found attached to the stent.During preparation of a 2.50mmx28mm synergy¿ drug-eluting stent, it was noted that a fiber particle was attached onto the stent strut.The procedure was completed with another 2.50mmx28mm synergy¿ drug-eluting stent.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The od of the stent was taken which is within the specification.There were visible white fibres intertwined with the stent struts.It was not possible to identify the fm (foreign material) fibres therefore further analysis - fourier transform infrared analysis (ftia) and scanning electron microscopy (sem) - was carried out.Analysis showed the fibres were situated between the stent struts and balloon surface.The fibres appeared to be silk with spectra displaying similar peak locations associated with cellulose based materials such as silk.The fibres also displayed a rod like structure similar to a typical silk fibre.However the origin of this fibre fm could not be fully confirmed.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.The bumper tip of the device showed no signs of damage.A visual and tactile examination found several slight kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion profile.The inner lumen and bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that a foreign matter was found attached to the stent.During preparation of a 2.50mmx28mm synergy¿ drug-eluting stent, it was noted that a fiber particle was attached onto the stent strut.The procedure was completed with another 2.50mmx28mm synergy¿ drug-eluting stent.No patient complications were reported and the patient's status was stable.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5913319
• MDR Text Key: 53444955
• Report Number: 2134265-2016-07628
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: H7493926228250
• Device Catalogue Number: 39262-2825
• Device Lot Number: 19030353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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