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

Model Number 10623

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 3.00mm x 38mm stent delivery system, catheter was returned for analysis.Examination of the stent identified the stent was fully separated from the delivery device.Stent damage and stretching was identified along the entire length of the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter was within max crimped stent profile measurement.The balloon cones were reviewed, and the balloon appeared to have been subjected to positive pressure and the balloon cones were relaxed.There was clear dried media inside the balloon and there were no signs of damage to the balloon.Examination of the tip found no damage.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.Device was tracked on 0.014 guidewire without issue.Device inflated with no issues to rated burst pressure, maintained pressure and deflated within 16 seconds.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on17jun2021.It was reported that stent is having difficulty in deployment.Lya 3.00 x 38 synergy ii des drug-eluting stent was advanced, however, during the first inflation to nominal pressure stent did not deploy correctly.The procedure was completed with a different device.There were no complications reported and the patient is stable.However, returned device analysis revealed stent damage.

• 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: 12052842
• MDR Text Key: 257893849
• Report Number: 2134265-2021-08063
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024934181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2019
• 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