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

Model Number 10602

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.The distal section of the shaft including the stent was not returned for analysis therefore analysis of stent profile could not be carried out.However, as part of the analysis, a review of the manufacturing data for the stent profile was performed.The distal section of the shaft including the balloon was not returned for analysis therefore analysis of balloon profile could not be carried out.The distal section of the shaft including the tip was not returned for analysis therefore analysis of tip profile could not be carried out.A visual and tactile examination of the hypotube found multiple severe kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the mid-shaft section found a break at the wire exit port/port bond.The distal section of the shaft was not returned for analysis.It appears as if the shaft was cut off as there is no evidence of shaft stretching indicating that excessive force was not applied to cause the break.A kink was also noted on the port bond.The cause of the shaft break cannot be determined the cause of the shaft break due to limited information provided in the complaint report.

Event Description

Reportable based on device analysis completed on 10jan2020.It was reported that device could not cross lesion.Following pre-dilatation with a 2.5x14mm emerge mr balloon, a 2.50 x 16 synergy ii drug eluting stent was unable to cross the lesion.No patient complications were reported.However, device analysis revealed shaft break.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9642606
• MDR Text Key: 178639504
• Report Number: 2134265-2020-00670
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024377318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• 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