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

Model Number 10621

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture and under-expansion of the stent occurred.The 70% stenosed target lesion was located in the proximal left anterior descending artery.Following deployment of a 2.50 x 28 synergy drug-eluting stent, post dilatation was performed with a 3.0 x 12 mm quantum nc balloon.After angiographic control, it was observed that there was an important under-expansion area in the stent body with an intra-stent haziness.Intravascular ultrasound revealed a fracture area of the newly implanted stent (discontinuation of the struts) and longitudinal retraction.A 2.75 x 38 mm drug-eluting stent was implanted to complete the procedure safely.The patient progressed well, without elevation of cardiac markers after intervention, and was discharged after 48 hours.No further patient complications were reported.

• 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: 9136457
• MDR Text Key: 161365279
• Report Number: 2134265-2019-11710
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0022755854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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