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

Model Number 10619

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Event Description

It was reported that device sterility was compromised.While the box of a 2.75 x 20 synergy stent was being opened, a cut in the sterile cover was noticed.The procedure was completed with another device.No patient complications resulted in relation to this event.

Event Description

It was reported that device sterility was compromised.While the box of a 2.75 x 20 synergy stent was being opened, a cut in the sterile cover was noticed.The procedure was completed with another device.No patient complications resulted in relation to this event.

Manufacturer Narrative

The synergy ous mr 2.75 x 20mm stent delivery system (sds), was returned for analysis within its open shelf carton and foil pouch.The coiled device was sealed inside the tyvek pouch.The shelf carton with labels of synergy xd 2.75x20mm lot 27377300, upn h7493926220270 use by date 2023-05-07 was found to be damaged in several areas.Several cuts/slashes were noted on the front of the shelf carton.The blue closure strip was open, and damage (bunching and scrunching) were noted on the left and bottom spine of the shelf carton.The foil pouch with labels of synergy xd 2.75x20mm lot 27377300, upn h7493926220270 used by date 2023-05-07 was found to have cuts/slashes which matched those on the shelf carton on the front.The foil pouch also had its seal ripped open.The tyvek pouch with labels of synergy xd 2.75x20mm lot 27377300, upn h7493926220270 used by date 2023-05-07 was found to be fully sealed with the coiled device inside however a cut/slash was found through the product label.

• 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: 13184062
• MDR Text Key: 283412027
• Report Number: 2134265-2021-16530
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0027377300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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