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

Model Number 10623

Device Problems Premature Activation (1484); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that stent damaged and premature deployment occurred.The 85% stenosed target lesion was located at mid left anterior descending artery (lad).A 3.50mm x 38mm synergy ii drug eluting stent was selected for dilation was advanced.However, it was reported "the stride of stent was untied" and "the stent was released".No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damaged and premature deployment occurred.The 85% stenosed target lesion was located at mid left anterior descending artery (lad).A 3.50mm x 38mm synergy ii drug eluting stent was selected for dilation was advanced.However, it was reported "the stride of stent was untied" and "the stent was released".No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is combination product.Device evaluated by mfr.: synergy ous mr 3.50 x 38 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage to proximal stent row 4 with stent struts lifted.The undamaged crimped stent 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 showed signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and the 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
• MDR Report Key: 8325481
• MDR Text Key: 135713547
• Report Number: 2134265-2019-01050
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: 12/02/2019
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0022231727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/03/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR