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 H7493926008400

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that stent migration occurred.The target lesion is located in the right coronary artery (rca).A 4.00 x16 synergy drug-eluting stent was deployed in the distal rca to treat the lesion.The lesion required a shorter stent to be placed more proximal, so a 4.00 x 8 synergy drug-eluting stent was deployed just proximal to the 4.00 x 16mm stent.Upon inflation, everything seemed to be in appropriate position and again a cine shot was taken; however, it was recognized that the 4.00 x 8 stent had migrated proximally by about 15mm.So another 4.00 x16 synergy drug-eluting stent was delivered to cover the distance between the first stent and the second stent; however, upon delivery through the 4.00 x 8mm synergy stent, it caught that stent and pushed it down adjacent to the original 4.00 x 16 synergy stent.The physician then chose to take a high pressure balloon, a 4.5 x 20 apex non-compliant and post dilated both the 4.00 x 16mm and the 4.00 x 8mm synergy stents in those exact positions and that completed the procedure.No further patient complications reported and the patient was safe and sound.

Manufacturer Narrative

Device evaluated by mfr.: a synergy ii us mr 4.00 x 8mm stent delivery system (sds) was returned for analysis without a stent.No stent returned.The balloon was reviewed.There was no stent on the balloon and the balloon folds were not present.It appeared that positive pressure was applied to the balloon and a vacuum pulled.No damage was noted to the balloon.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no issues with the tip.No other issues were identified during the product analysis.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that stent migration occurred.The target lesion is located in the right coronary artery (rca).A 4.00 x16 synergy drug-eluting stent was deployed in the distal rca to treat the lesion.The lesion required a shorter stent to be placed more proximal, so a 4.00 x 8 synergy drug-eluting stent was deployed just proximal to the 4.00 x 16mm stent.Upon inflation, everything seemed to be in appropriate position and again a cine shot was taken; however, it was recognized that the 4.00 x 8 stent had migrated proximally by about 15mm.So another 4.00 x16 synergy drug-eluting stent was delivered to cover the distance between the first stent and the second stent; however, upon delivery through the 4.00 x 8mm synergy stent, it caught that stent and pushed it down adjacent to the original 4.00 x 16 synergy stent.The physician then chose to take a high pressure balloon, a 4.5 x 20 apex non-compliant and post dilated both the 4.00 x 16mm and the 4.00 x 8mm synergy stents in those exact positions and that completed the procedure.No further patient complications reported and the patient was safe and sound.

• 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: 6878239
• MDR Text Key: 86692467
• Report Number: 2134265-2017-09038
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: 08714729840015
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2017
• Device Model Number: H7493926008400
• Device Catalogue Number: 39260-0840
• Device Lot Number: 19836081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• 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