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

Model Number 10620

Device Problems Shipping Damage or Problem (1570); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 2.25 x 24 synergy drug-eluting stent was received damaged along with a box that was damaged and crushed.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.25 x 24 stent delivery system was returned for analysis.Two blue closure strips were attached on top of one another.The bottom closure strip was opened with top one still intact.All labelling is legible, patient peel offs intact, slight damage noted to corner of box.No ifu inside shelf carton.All labelling legible, patient peel offs intact.No signs of damage.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.A 2.25 x 24 synergy drug-eluting stent was received damaged along with a box that was damaged and crushed.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10801903
• MDR Text Key: 215088983
• Report Number: 2134265-2020-15179
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0025863899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1