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

Model Number 10622

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the femoral artery.The completely occluded, eccentric target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.After crossing the lesion with a wire, pre-dilation was performed with a 2.5x12mm balloon obtaining a flow.Subsequently, a 2.75 x 32mm synergy ii drug-eluting stent was implanted where eccentric calcification was noted proximal to the implanted stent.It was then found after post dilation under fluoroscopy, that a stent fracture occurred.The procedure was completed by covering the gap with another synergy stent.No 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8067366
• MDR Text Key: 127052236
• Report Number: 2134265-2018-62763
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2019
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0022104036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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: 54 YR