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

Model Number 10619

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.50 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the distal stent region were noted to be lifted form their crimped position and pulled in a proximal direction.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 damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.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.

Event Description

Reportable based on device analysis completed on 08 sep 2020.It was reported that crossing difficulties were encountered.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50 x 20mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was in good condition.However, returned device analysis revealed stent damage.

• 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: 10606974
• MDR Text Key: 209186219
• Report Number: 2134265-2020-13541
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

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: 12/15/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0024014695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• 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: 71 YR