MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10600

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent migration and positioning difficulties were encountered.Vascular access was obtained via the right radial artery.The target lesion was located in an ostium of the right coronary artery.A 3.50 x 8 mm synergy drug-eluting stent was deployed in the ostium.However, it was observed that the stent was positioned in the aorta and the non-bsc guide catheter slipped inside of it.Since the guide catheter was smaller than the stent, the stent became stuck on the out side of the catheter.Another 3.50 x 12 mm synergy drug-eluting stent was attempted to deploy in the ostium; however, the whole system was moving in and out of ostial and the guide also kept engaging and disengaging.The stent was inflated inside the aorta and it got set again on the outside of the guide catheter.The two stents were kind of sitting on the outside of the guide catheter.Subsequently, a 4.5 mm balloon was advanced and inflated out the outside of the guide catheter to capture both stents and would not slide off in the moment of pulling them back into the right radial sheath.However, upon pulling the stents back, it seemed that both stents were stuck around the brachial region of the arm and could not be removed.Both stents were left inside the patient's body.No complications were reported in the arm where the stents are at.The ostium was ballooned and the procedure was completed.No patient complications were reported and the patient's status was fine.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8700907
• MDR Text Key: 148057439
• Report Number: 2134265-2019-06062
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840008
• UDI-Public: 08714729840008
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0023436793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR