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

Device Problem Device-Device Incompatibility (2919)

Patient Problem Reocclusion (1985)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that in-stent restenosis (isr) occurred.The target lesion was an area of in-stent restenosis (isr) located in the left main trunk (lmt).A 100mmx3.50mm wolverine coronary cutting balloon was advanced for treatment.However, resistance was felt and the balloon got caught in the stent strut of the 3.5x16 synergy; which was placed a year ago.Subsequently, the blade was found bent when pulled out carefully.The procedure was not completed due to the event.No patient complications were reported.

• 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: 9072508
• MDR Text Key: 158711711
• Report Number: 2134265-2019-11204
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GUIDE CATHETER, HEARTRAIL II 6F BL 4.0 SH; GUIDEWIRE, SION BLUE, RADIFOCUS; IMAGING CATHETER, OPTICROSSHD; INFLATION DEVICE, E-CHARGE 30 INDEFLATOR; STENT, 4.0X9 ULTIMASTER TANSEI
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR