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

Model Number 10619

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.The 85% stenosed, 20mm x 4mm target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).A 4.00 x 20mm synergy stent was advanced to treat the lesion.However, the distal end of the stent struts was lifted due to calcification in the proximal end of the rca.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.The 85% stenosed, 20mmx4mm target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).A 4.00x20mm synergy stent was advanced to treat the lesion.However, the distal end of the stent struts was lifted due to calcification in the proximal end of the rca.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: synergy ous mr 4.00 x 38 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the distal stent strut rows were noted to be lifted and pulled in all directions.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was 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 and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen 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: 8952805
• MDR Text Key: 156300405
• Report Number: 2134265-2019-10498
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

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: 07/13/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0023225013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 69