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 H7493926016350

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-03819.It was reported that product sterility was compromised.Vascular access was obtained via the radial artery.The target lesion was located in a coronary artery.After a guide catheter was placed in the lesion, a 3.50 x 38mm synergy ii drug-eluting stent (des) was advanced but it became stuck within the guide catheter in the radial artery.During removal, difficulty was encountered and it was noted that the stent was dislodged inside the guide catheter and it ripped off.The physician retrieved the dislodged stent using a snare.A 3.50 x 16mm synergy ii (des) was selected for use; however, the stent accidentally slipped and fell on the ground.The device was not used to the patient.The physician placed two more stents and the procedure was completed.No further patient complications were reported and the patient's status was okay.

• 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: 7496853
• MDR Text Key: 107699508
• Report Number: 2134265-2018-03820
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2018
• Device Model Number: H7493926016350
• Device Catalogue Number: 39260-1635
• Device Lot Number: 21436669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2017
• 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