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 H7493926020350

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon removal difficulties were encountered, stent migration and stent damaged occurred.The target lesion was located in the left anterior descending (lad) artery.A 3.50 x 20mm synergy ii drug-eluting stent was deployed.Following post dilation, the balloon was deflated but could not be removed from the stent.The stent then moved into the left main (lm) artery and was elongated approximately 21.5mm per intravascular ultrasound.The stent in lm was post dilated with a 4.5x8 non-bsc balloon catheter and lad was dilated with a 4.0x15 non-bsc balloon catheter without stenting.The procedure was then completed.No patient complications were reported and the patient was doing well.

• 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: 7151055
• MDR Text Key: 95929258
• Report Number: 2134265-2017-12834
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: 08714729840183
• 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
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: H7493926020350
• Device Catalogue Number: 39260-2035
• Device Lot Number: 0021043056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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
• Treatment: BALLOON CATHETER: NC TREK 4.0X15MM; BALLOON CATHETER: NC TREK 4.5X8MM
• Patient Outcome(s): Required Intervention