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

Model Number 9536

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Date of event: estimated based off aware date of 10feb2020.

Event Description

It was reported via social media that vessel perforation occurred.The patient's vessels were severely calcified with lesions located in the left main trunk (lmt), left anterior descending (lad) and left circumflex (lcx) arteries.A rotablator (1.25mm and 1.5mm burr) was used with opticross guidance in the lad.A 2.25 x 32mm synergy stent was uneventfully placed in the mid lad followed by a 3.0 x 38mm synergy stent from the mid to proximal lad overlapping the previous stent.After placement of the 3.0 x 38mm stent, the delivery system was removed and a large perforation appeared very close to the overlap region between the two stents at a bend in the lad.A covered stent was used to seal the perforation using ping-pong technique.A guidezilla was then used and supported the rotablator (1.25mm burr) to the left main trunk/proximal lcx.A 2.25 x 28mm synergy stent was implanted in the lcx and a 4.0 x 12mm synergy stent was implanted in the lmt.The case was finished with an excellent result.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9748314
• MDR Text Key: 180806580
• Report Number: 2134265-2020-02025
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9536
• Device Catalogue Number: 9536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• 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