MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number UNK744

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned therefore analysis of complaint device could not be performed.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-02243 it was reported that stent migration occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal to mid left anterior descending artery.Following pre-dilation with a 2.0x15 emerge balloon catheter, a synergy¿ drug-eluting stent was implanted for treatment.An opticross¿ imaging catheter was then inserted for intravascular ultrasound; however difficulties pulling back the imaging catheter were encountered.The stent strut was caught with the imaging catheter and the stent migrated.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 7381968
• MDR Text Key: 103857015
• Report Number: 2134265-2018-02675
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR