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

Lot Number 0026017289

Device Problems Deflation Problem (1149); Material Rupture (1546); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in mildly tortuous and severely calcified right coronary artery.A 3.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during inflation, only the distal part was inflated and the balloon ruptured.A leak of contrast was observed from the proximal part of the balloon.The device was removed and the procedure was completed with another 3.5x8mm synergy xd drug-eluting stent.There were no patient complication nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 3.50 x 32 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the proximal and distal stent regions were noted to be lifted from their crimped position and pulled distally (ref.Photo 02).The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of some positive pressure were noted on the proximal balloon cone as it appeared slightly inflated.No signs of positive pressure noted on the distal balloon cone.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found a fracture in the lasercut region noted at 36.5 cm proximal to the distal end of the tip and a break of the hypotube shaft located at 27.9cm distal to the distal end of the strain relief.Additionally, multiple kinks were noted along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The device was soaked for 24 hours in a water bath at 37 degrees celsius and was attached to an encore inflation device.An attempt was then made to inflate the balloon to 16 atmospheres (atm) to the broken region of the hypotube shaft however, pressure was unable to maintained above 2atm as inflation liquid was observed leaking from the fracture site in the lasercut section of the hypotube shaft.The lasercut region of the shaft was cut 1 cm distally to the fractured site and an inflation aid was used to attempt to inflate the device.This attempt was successful, and the balloon inflated to 16 atm, maintained pressure for 1 minute and deflated within 15 seconds with the stent being successfully deployed.The encore inflation device was verified before and after the procedure.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in mildly tortuous and severely calcified right coronary artery (rca).A 3.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during inflation, only the distal part was inflated and the balloon ruptured.A leak of contrast was observed from the proximal part of the balloon.The device was removed and the procedure was completed with another 3.5x8mm synergy xd drug-eluting stent.There were no patient complication nor injuries reported.It was further reported that after the deployment of another stent in rca, the device was inserted.There was a calcification at the aorta ostium,so the product was moved for positioning.There was no difficulty of insertion and no bending of lesion.The balloon was inflated below the nominal pressure.The device was not possible to deflate sufficiently and it was pulled out strongly with the distal part slightly inflated.After the device was pulled out from the patient's body, a kink was observed on the device.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11186786
• MDR Text Key: 227522288
• Report Number: 2134265-2021-00424
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Lot Number: 0026017289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1