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 H7493926024400

Device Problems Bent (1059); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that stent damage occurred and a foreign matter was found.During preparation of a 4.00 x 24 synergy ii drug-eluting stent, a distal stent strut was lifted upon removal of the stent protector and a piece of "fuzz" was found on the stent.There was no roughness encountered and the stent did not touch the table before being placed on the wire.The procedure was completed with no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: synergy ii us, mr, 4.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that the first distal strut was lifted from the stent profile, stretched and pulled in a distal direction.The product stent protector was not returned for analysis with the device.There were visible white fibres intertwined along the entire length of the stent.It was not possible to identify the fm (foreign material) fibres therefore further analysis; fourier transform infrared analysis (ftia) was carried out.Analysis showed the fibres were situated between the stent struts and balloon surface.Two of the fibres were removed and analyzed using fourier transform infrared (ftir).The fibres appeared to be cotton with spectra displaying similar peak locations associated with cellulose based materials such as cotton.The fibres also displayed a twist in the structure that is a characteristic of cotton fibres.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.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 multiple kinking on the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found no issues with their profile.The bi-component bond showed no signs of damage or strain.No other issues were identified during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that stent damage occurred and a foreign matter was found.During preparation of a 4.00 x 24 synergy ii drug-eluting stent, a distal stent strut was lifted upon removal of the stent protector and a piece of "fuzz" was found on the stent.There was no roughness encountered and the stent did not touch the table before being placed on the wire.The procedure was completed with no patient complications reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5683924
• MDR Text Key: 46064370
• Report Number: 2134265-2016-04402
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 04/28/2016

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: 09/04/2016
• Device Model Number: H7493926024400
• Device Catalogue Number: 39260-2440
• Device Lot Number: 18418572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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