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

Model Number 10618

Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 02/26/2022

Event Type  malfunction  

Event Description

It was reported that device entrapment and stent damage occurred.The patient was diagnosed with small vessel disease (svd) of the left circumflex (lcx) artery.Following pre-dilatation, a 2.25 x 16 synergy drug eluting stent was loaded onto the guidewire.However, during introduction, the stent got stuck on the guidewire outside the patient and the stent was damaged.The physician removed the device by cutting the guidewire.The procedure was completed with another of the same device and a new guidewire.No patient complications were reported and the patient condition post procedure was stable.

Event Description

It was reported that stent got stuck on guidewire occurred.The patient was diagnosed with small vessel disease (svd) of the left circumflex (lcx) artery.Following pre-dilatation, a 2.25 x 16 synergy drug eluting stent was loaded onto the guidewire.However, during introduction, the stent got stuck on the guidewire outside the patient and the stent was damaged.The physician removed the device by cutting the guidewire.The procedure was completed with another of the same device and a new guidewire.No patient complications were reported and the patient condition post procedure was stable.

Manufacturer Narrative

The synergy ous mr 2.25 x 16mm stent delivery system (sds) was returned for analysis.The device was returned with a segment of customer guidewire inserted.The guidewire diameter measured 0.014.This segment of guidewire was removed without issue.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 marker bands.The crimped stent od (outer diameter) was measured 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 identified tip damage.A visual and tactile examination of the hypotube identified no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified a 9.5 cm length of stretching on the polymer shaft distal to the exchange port, a polymer shaft kink at 7 cm distal to the exchange port, and bunching on the polymer shaft inner at 5.5 cm proximal to the distal tip.The device could not be loaded or tracked through a 0.014 guidewire due to the extent of the polymer shaft 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: 13766604
• MDR Text Key: 287337646
• Report Number: 2134265-2022-02505
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 06/16/2022

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: 01/28/2023
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0026767327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Asian