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

Model Number H7493919816300

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Pain (1994); ST Segment Elevation (2059)

Event Type  Injury  

Manufacturer Narrative

Complainant name: (b)(6) age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: the device was not returned for analysis. the batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that st elevation and stent elongation occurred.The target lesion was located in the descending artery (da).A 16x3.00mm synergy¿ drug-eluting stent was implanted to treat the lesion.A few hours later, the patient was in pain and an st-segment elevation was noted in the electrocardiogram.The following day, the patient was treated again.When the physician looked at the stent there appeared to be some recoil.Subsequently, a 3.5x16mm stent was advanced to the vessel.However, when the new stent was advanced through the previously implanted 16x3.00mm synergy¿ stent, the physician realized that the implanted stent was much longer than the new stent.The 3.5x16mm stent was successfully deployed and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• 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: 6665122
• MDR Text Key: 78345613
• Report Number: 2134265-2017-06192
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493919816300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/23/2017
• 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