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

Model Number 10620

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 2.50 x 24 synergy drug-eluting stent was selected for use.However, when trying to insert the stent into the guidewire, the distal part of the stent was noticed to be deformed.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr.: synergy ous mr 2.50 x 24mm stent delivery system, catheter was returned for analysis.A visual examination of the stent found stent damage.The distal struts were stretched and extended towards the distal markerband.The undamaged stent outer diameter was measured and the result 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 tip damage.A visual and tactile examination of the hypotube found no issues.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 90% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 2.50 x 24 synergy drug-eluting stent was selected for use.However, when trying to insert the stent into the guidewire, the distal part of the stent was noticed to be deformed.The procedure was completed with a different device.There were no patient complications reported.

• 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: 10391782
• MDR Text Key: 202404351
• Report Number: 2134265-2020-10944
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0024732598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: GUIDEPLUS; GUIDE CATHETER: GUIDEPLUS; GUIDE CATHETER: GUIDEPLUS