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

Model Number 10619

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.The patient presented with myocardial infarction.Vascular access was obtained via the right femoral artery.The 70% stenosed, concentric, de novo target lesion with a bend between 45 and 90 degrees was located in the moderately tortuous and severely calcified left anterior descending artery.Following pre-dilatation using 2.0x15mm and 2.5x15mm nc emerge balloons, intravascular ultrasound (ivus) was done to assess the vessel.Further dilatation was done with a 2.75x15mm nc emerge balloon and a 3.0x12mm non-bsc lithotripsy balloon but the latter failed to deliver continuous pulses.Subsequently, a 2.50x20mm synergy ii drug-eluting stent was introduced with significant resistance encountered during both advancing and operation.Before the stent was deployed at the target lesion.Post-dilatation was performed with the same 2.75x15mm nc emerge balloon and with a new 3.0x12mm non-bsc lithotripsy balloon but the latter failed to deliver continuous pulses again.Post ivus, the physician decided to post-dilate with a 3.0x15mm non-bsc super high pressure balloon; however, after a second inflation at 25 atmospheres, it was noticed via imaging that the stent appeared to be fractured.No further patient complications were reported and the patient was stable.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 9253160
• MDR Text Key: 164324954
• Report Number: 2134265-2019-13012
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/29/2019

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 Expiration Date: 10/19/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0023708926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR