MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926012300

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as 2134265-2017-03626.It was reported that foreign material was noted.The target lesion was located in a coronary artery.During a percutaneous coronary intervention (pci), a 3.00mmx12mm synergy ii drug-eluting stent was selected for treatment.Initial attempts of crossing the device to the lesion were made but were unsuccessful.The undeployed 3.00mmx12mm synergy ii drug-eluting stent was then removed from the runway guide catheter, however it was noted that a "long plastic string" was attached to the stent.The physician then decided to remove the guide, wire and the stent as the concern was that the particulate was either from the stent delivery catheter or the inner lining of the guide.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination of the crimped stent revealed no issues.There were no signs of damage or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result 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.A visual and tactile examination of the hypotube was performed and there were no signs of kinks or damage to the hypotube.An examination of the shaft polymer extrusion revealed no issues.There were no signs of damage to the inner or outer shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.The tip was visually and microscopically examined and damage was noted.Foreign matter (fm) was returned separate to the device and was sent for characterization using fourier transform infra-red spectroscopy (ftir).The fm was 60mm in length.There was a braid pattern indented in the fm.The spectrum produced was very similar to that of ptfe (polytetrafluoroethylene).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 cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

Same case as 2134265-2017-03626.It was reported that foreign material was noted.The target lesion was located in a coronary artery.During a percutaneous coronary intervention (pci), a 3.00mmx12mm synergy ii drug-eluting stent was selected for treatment.Initial attempts of crossing the device to the lesion were made but were unsuccessful.The undeployed 3.00mmx12mm synergy ii drug-eluting stent was then removed from the runway guide catheter, however it was noted that a "long plastic string" was attached to the stent.The physician then decided to remove the guide, wire and the stent as the concern was that the particulate was either from the stent delivery catheter or the inner lining of the guide.No patient complications were reported and the patient's status was good.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6490279
• MDR Text Key: 72805453
• Report Number: 2134265-2017-03625
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: (01)08714729840053(17)20171130(10)0020034879
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H7493926012300
• Device Catalogue Number: 39260-1230
• Device Lot Number: 0020034879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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