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

Model Number 10618

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.75 x 16mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.The stent was kinked, and stent struts lifted in struts rows 5 and 6 from the proximal end and strut rows 5 and 6 from the distal end.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 issues.A visual and tactile examination of the hypotube found a kink in the hypotube shaft 135mm distal to the distal end of the strain relief.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 25-sep-2020.It was reported that crossing difficulties were encountered.The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.Following pre-dilation with a 2.0x15mm non-boston scientific balloon catheter, a 2.75 x 16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion due to the calcification and angulation.The procedure was completed with a different device and no patient complications were reported.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: 10680695
• MDR Text Key: 211458045
• Report Number: 2134265-2020-14216
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023867285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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: 73 YR