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

Model Number 10620

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that string snaggled on mandrel encountered.The target lesion was located in the right coronary artery.A 3.50 x 24 synergy drug-eluting stent was selected for use to treat a lesion.However, during preparation, there was resistance met when trying to pull out the mandrel and it was noted that the physician found something like string entangled in the mandrel.The procedure was completed with a different device.No patient serious injury or adverse event were reported.

Event Description

It was reported that string entangled on mandrel encountered.The target lesion was located in the right coronary artery.A 3.50 x 24 synergy drug-eluting stent was selected for use to treat a lesion.However, during preparation, there was resistance met when trying to pull out the mandrel and it was noted that the physician found something like string entangled in the mandrel.The procedure was completed with a different device.No patient serious injury or adverse event were reported.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ous mr 3.50 x 24 mm stent delivery system was returned for analysis with stent protector and mandrel attached.A visual examination of the alleged foreign material (fm) found a white string-like material on the product mandrel at the port bond site, 118.5cm distal to the distal end of the strain relief.The fiber appeared to be wrapped around the mandrel at the port bond site and a portion of the material was inside the port bond.The device was returned with the product mandrel and stent protector still attached.The device was returned with evidence of the mandrel movement, as the pig-tail was 3cm distal to the distal tip.The mandrel could not be removed as the fm was blocking the movement.The mandrel and stent protector were removed distally without issue, once the obstructing fm was taken from the port bond site.Fourier transform infrared spectroscopy (ftir) analysis indicated that the fm is a cotton-based material.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 marker bands.The crimped 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 found multiple kinks.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.

• 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: 9009741
• MDR Text Key: 157880062
• Report Number: 2134265-2019-10519
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0022732715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1