MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10604

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Event date: estimated based on aware date of (b)(6) 2020.Device is a combination product.

Event Description

This device was received with a note written on the box "defective- fuzz on stent straight out hoop".However, upon review of the device, it was revealed that a foreign material was present on the device.

Event Description

This device was received with a note written on the box "defective- fuzz on stent straight out hoop".However, upon review of the device, it was revealed that a foreign material was present on the device.

Manufacturer Narrative

B3: event date - estimated based on aware date of (b)(6) 2020.Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.75 x 24 mm stent delivery system catheter was returned for analysis coiled in its hoop.The hoop was enclosed within an opened shelf carton.Some creasing damage was noted to box and the seal was open.Written in marker on the box was: '* defective * fuzz on stent straight out of hoop.' when withdrawing the device from the hoop a piece a fibrous fm (foreign matter) was noted and it was not attached to the hoop or the device.The fibrous fm was white in color and approximatively 3mm in length.The fm was placed in a labeled container and awaits ftir testing.No product mandrel or stent protector was returned with the device.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The sample was compared to a library of samples from the data base of the material characterization lab including different materials present in the des manufacturing cleanroom however no matches were found.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10111478
• MDR Text Key: 193417335
• Report Number: 2134265-2020-07226
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: 08714729840220
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023208027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1