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

Model Number 10600

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

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

Event Date 04/24/2021

Event Type  malfunction  

Event Description

It was reported that foreign material present on the device.The target lesion was located in the left anterior descending artery (lad).A 3.00 x 8 synergy stent was selected for use and was opened in sterile fashion.Upon removing the stent from the hoop, a clear piece of adhesive was noted.The device never went into the patient.A new stent was opened to complete the procedure.

Manufacturer Narrative

B5.Describe event or problem- updated.

Event Description

It was reported that foreign material present on the device.The target lesion was located in the left anterior descending artery (lad).A 3.00 x 8 synergy stent was selected for use and was opened in sterile fashion.Upon removing the stent from the hoop, a clear piece of adhesive was noted.The device never went into the patient.A new stent was opened to complete the procedure.It was further reported that the adhesive was on the mid shaft of the balloon.

Manufacturer Narrative

Device evaluation by mfr: the synergy ii us mr 3.00 x 8mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured by snap gauge and was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube identified no issues.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.Mid shaft bond od was measured for reference using a calibrated snap gauge was not within an acceptable measurement.No other issues were noted during product analysis.

Event Description

It was reported that foreign material present on the device.The target lesion was located in the left anterior descending artery (lad).A 3.00 x 8 synergy stent was selected for use and was opened in sterile fashion.Upon removing the stent from the hoop, a clear piece of adhesive was noted.The device never went into the patient.A new stent was opened to complete the procedure.It was further reported that the adhesive was on the mid shaft of the balloon.

• 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: 11821474
• MDR Text Key: 250642015
• Report Number: 2134265-2021-06029
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 06/23/2021

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: 10/07/2022
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0026175416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 06/17/2021
• Supplement Dates FDA Received: 05/27/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1