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

Lot Number 0026840779

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  Injury  

Event Description

It was reported that a balloon rupture occurred.A 4.00 x 24mm synergy xd drug eluting stent balloon was selected for treatment of an infarction, but while attempting to place the stent, the balloon ruptured.It was noted that the balloon remained in it, and the stent did not deploy.It was noted that there was major risk of cardiac arrest due to obstruction of the artery by the balloon.No further patient complications were reported in relation to this event.

Event Description

It was reported that a balloon rupture occurred.A 4.00 x 24mm synergy xd drug eluting stent balloon was selected for treatment of an infarction, but while attempting to place the stent, the balloon ruptured.It was noted that the balloon remained in it, and the stent did not deploy.It was noted that there was major risk of cardiac arrest due to obstruction of the artery by the balloon.No further patient complications were reported in relation to this event.It was further reported that after the balloon rupture a second physician came to help the first physician with the removal of the balloon from the stent.This was during a stemi procedure the target lesion was located in a non calcified and non tortuous circumflex (cx).A 15mm x 2.5 emerge balloon was advanced to predilate the lesion, and crossed the lesion successfully.It was noted that the 4.00 x 24mm synergy xd stent was deployed, but not completely.The stent balloon was inflated at 10 atmospheres, but the pressure of the inflation device could not be maintained due to the perforated balloon.It was noted that blood was observed in the inflation device following the balloon rupture.Several attempts were performed to remove the balloon, but it remained stuck to the stent.It was noted that during this time, the patient was doing well, without any signs of pain because there was blood flow in the artery.After 20 minutes, and several attempts, the balloon was removed the stent.There were no patient complications resulted in relation to this event.The patient was reported to be fine without consequences.

Event Description

It was reported that a balloon rupture occurred.A 4.00 x 24mm synergy xd drug eluting stent balloon was selected for treatment of an infarction, but while attempting to place the stent, the balloon ruptured.It was noted that the balloon remained in it, and the stent did not deploy.It was noted that there was major risk of cardiac arrest due to obstruction of the artery by the balloon.No further patient complications were reported in relation to this event.It was further reported that after the balloon rupture a second physician came to help the first physician with the removal of the balloon from the stent.This was during a stemi procedure the target lesion was located in a non calcified and non tortuous circumflex (cx).A 15mm x 2.5 emerge balloon was advanced to predilate the lesion, and crossed the lesion successfully.It was noted that the 4.00 x 24mm synergy xd stent was deployed, but not completely.The stent balloon was inflated at 10 atmospheres, but the pressure of the inflation device could not be maintained due to the perforated balloon.It was noted that blood was observed in the inflation device following the balloon rupture.Several attempts were performed to remove the balloon, but it remained stuck to the stent.It was noted that during this time, the patient was doing well, without any signs of pain because there was blood flow in the artery.After 20 minutes, and several attempts, the balloon was removed the stent.There were no patient complications resulted in relation to this event.The patient was reported to be fine without consequences.

Manufacturer Narrative

Device evaluated by mfr: a 4.00 x 24mm synergy xd stent delivery system (sds) was returned for analysis.The device was returned with no stent attached.The crimped stent od (outer diameter) was measured and was within maximum crimped stent profile measurement.The balloon returned in a deflated state.Solidified blood like media was visible inside the balloon.Microscopic examination of the balloon material identified a hole at approximately 3mm distal from the proximal marker band.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified a hypotube break located approximately 71.9cm distal to the distal strain relief, as well as multiple hypotube kinks at several locations along the hypotube shaft.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 XD
• 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: 12408045
• MDR Text Key: 269470008
• Report Number: 2134265-2021-11111
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Lot Number: 0026840779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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 Outcome(s): Other