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

Model Number 10621

Device Problem Deflation Problem (1149)

Patient Problems Air Embolism (1697); Stenosis (2263)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that balloon slow deflation occurred and patient experienced vessel occlusion and air embolism.The target lesion was located in a moderately tortuous coronary artery.A 3.00 x 28mm synergy ii drug-eluting stent was noted with a kink at 20-30cm from the distal tip of the delivery system.The device was advanced and inflated twice for 2 seconds.It was noted to decrease at around 11 atmospheres so the device was removed and tested outside the patient's body which was observed to deflate longer than usual.At the same time, no flow and air embolism occurred which was treated with intra-aortic balloon pump.The procedure was completed with a different device.No further complications were noted.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ous mr 3.00 x 28 mm stent delivery system was returned for analysis without the stent attached.The stent was not returned for analysis as it was deployed.The balloon was returned for analysis in a deflated state, no visible defects on the balloon.Crimp markings were evident on the exposed balloon wall.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks and a fracture on the hypotube lasercut region 109.8cm distal to distal end of the strain relief.The core-wire is visible at the fracture site.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The balloon was unable to inflate to its rated burst pressure due to the fractured lasercut region.The inflation device was verified before and after use.During the inflation test, a leak was noted at the fracture site.No other issues were identified during the product analysis.

Event Description

It was reported that balloon slow deflation occurred and patient experienced vessel occlusion and air embolism.The target lesion was located in a moderately tortuous coronary artery.A 3.00 x 28mm synergy ii drug-eluting stent was noted with a kink at 20-30cm from the distal tip of the delivery system.The device was advanced and inflated twice for 2 seconds.It was noted to decrease at around 11 atmospheres so the device was removed and tested outside the patient's body which was observed to deflate longer than usual.At the same time, no flow and air embolism occurred which was treated with intra-aortic balloon pump.The procedure was completed with a different device.No further complications were noted.

• 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: 8728841
• MDR Text Key: 149013354
• Report Number: 2134265-2019-06453
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0022831586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention