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

Model Number 10622

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.The 92% stenosed target lesion is located in the proximal end of the left circumflex artery.A 4.00x32mm synergy ii drug-eluting stent was advanced but failed to cross lesion and during withdrawal, the stent struts were found lifted.The procedure was completed with another of 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 32mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.A mid-stent strut was noted to be lifted from its crimped position.The undamaged stent outer diameter 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 damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile 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.

Event Description

It was reported that stent damage occurred.The 92% stenosed target lesion is located in the proximal end of the left circumflex artery.A 4.00x32mm synergy ii drug-eluting stent was advanced but failed to cross lesion and during withdrawal , the stent struts were found lifted.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.

• 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: 9650193
• MDR Text Key: 178646760
• Report Number: 2134265-2020-00774
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0022451987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 68