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

Model Number 10603

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

It was reported that stent premature deployment occurred.The target lesion was located in the right coronary artery.After pre-dilation with a 3.0mm emerge balloon catheter, a 3.50 x 20mm synergy ii drug-eluting stent was advanced with guide catheter.However, the balloon had difficulty inflating while deploying.As a result, the stent was implanted proximal to the lesion.No patient complications nor harm were noted.

Manufacturer Narrative

Device evaluated by mfr: synergy ii us mr 3.50mm x 20mm stent delivery system was returned for analysis.An examination of the device identified that the stent had not been returned with the device as it was implanted in the patient.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture is within max crimped stent profile measurement.The balloon cones were reviewed, and the balloon cones had signs of partial inflation, the crimp stent markings were visible on the balloon body.Examination of the tip found no tip damage.Examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a tear noted on the shaft polymer extrusion starting at the port bond and continuing distally for 2.2 cm.A review of the vacuum decay time data was performed and showed this device passed this test.Attempts to inflate the balloon failed due to a leak from the tear identified in the shaft polymer extrusion.The encore device was verified before and after the inflation using druck gauge at 16 atmospheres.No other issues were identified during the product analysis.

Event Description

It was reported that stent premature deployment occurred.The target lesion ws located in the right coronary artery.After pre-dilation of a 3.0mm emerge balloon catheter, a 3.50 x 20mm synergy ii drug-eluting stent was advanced with guide catheter.However, the balloon had difficulty inflating while deploying.As a result, the stent was implanted proximal than the lesion.No patient complications nor harm were noted.

• 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: 11178259
• MDR Text Key: 227058278
• Report Number: 2134265-2021-00363
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0025652255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1