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

Model Number 10621

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that incorrect labeling occurred.The 85% stenosed, 28mm x 3.0mm target lesion was located in the severely tortuous and moderately calcified left circumflex artery.A 3.00 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent could not cover the bifurcated lesion as the stent was thought to be shorter that what was specified in the device packaging.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent length was measured, and the result was within the stent length measurement.The crimped stent outer diameter was measured and the result was within the 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 found no issues with the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was returned with box packaging and foil pouch packing.The packaging details were in alignment with the returned device details.No issues were identified during the product analysis.

Event Description

It was reported that incorrect labeling occurred.The 85% stenosed, 28mm x 3.0mm target lesion was located in the severely tortuous and moderately calcified left circumflex artery.A 3.00 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent could not cover the bifurcated lesion as the stent was thought to be shorter that what was specified in the device packaging.The procedure was completed with another of the same device.No patient complications were reported and the patient 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: 10045114
• MDR Text Key: 191009484
• Report Number: 2134265-2020-05702
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0023922387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 79