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

Model Number 10632

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 44mm x 3.00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following pre-dilation, a 3.00 x 48mm synergy drug-eluting stent (des) and a 32 x 3.00mm promus premier select des were advanced for treatment.However, both devices failed to cross the lesion and the stent struts got damaged.Both devices were removed and the procedure was successfully completed with a 2.50x24mm and 3.00x24mm promus premier select des.No patient complications were reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via femoral artery.The 90% stenosed, 44mm x 3.00mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 3.00 x 48 synergy ii drug-eluting stent was advanced, however failed to cross the lesion.Furthermore, the stent struts got damaged.The device was removed and completed the procedure with another of the same device.There were no complications reported and the patient is stable.

Manufacturer Narrative

Device evaluated by mfr: the synergy ous mr 3.00 x 48 mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the mid struts lifted.The stent showed no signs of movement and was set between the proximal and distal marker bands.The undamaged crimped stent od (outer diameter) was measured using snap gauge and 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 examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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: 13120315
• MDR Text Key: 283151428
• Report Number: 2134265-2021-16357
• 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: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027638374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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: 52 YR
• Patient Sex: Male