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

Lot Number 0029219462

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that removal difficulties and a shaft break occurred.On (b)(6) 2023, a 3.50 x 12mm synergy drug-eluting stent (des) was implanted in the left main trunk (lmt) to left anterior descending artery (lad) without any issues being encountered.On (b)(6) 2023, presented for treatment of the 95% stenosed target lesion located in the moderately tortuous and moderately calcified mid lad.Following pre-dilation, the 2.50 x 38 mm synergy xd des was advanced but was unable to cross the target lesion.A non-boston scientific (non-bsc) guide extension catheter was used to try to cross the lesion but the 2.50 x 38 mm synergy xd got stuck at the previously implanted 3.50 x 12mm synergy stent and was unable to cross.An attempt was made to remove the 2.50 x 38mm synergy xd in order to perform more pre-dilation.However, when the stent was pulled forcefully, the shaft was separated mid shaft and remained in the guide extension catheter.A 2.0 mm non-bsc balloon was inserted into the guide extension catheter and inflated to remove the detached shaft.It was noted that the previously implanted stent was explanted and also removed.The physician thought the guide extension catheter might have damaged the implanted stent and that was why it got stuck.After confirmation under fluoroscopy and intravascular ultrasound, the decision was made to continue treatment.Stenting was done from the lesion to the site of the explanted stent to successfully complete the procedure.There was no injury to the patient.

Event Description

It was reported that removal difficulties and a shaft break occurred.On (b)(6) 2023, a 3.50 x 12mm synergy drug-eluting stent (des) was implanted in the left main trunk (lmt) to left anterior descending artery (lad) without any issues being encountered.On (b)(6) 2023, presented for treatment of the 95% stenosed target lesion located in the moderately tortuous and moderately calcified mid lad.Following pre-dilation, the 2.50 x 38 mm synergy xd des was advanced but was unable to cross the target lesion.A non-boston scientific (non-bsc) guide extension catheter was used to try to cross the lesion but the 2.50 x 38 mm synergy xd got stuck at the previously implanted 3.50 x 12mm synergy stent and was unable to cross.An attempt was made to remove the 2.50 x 38mm synergy xd in order to perform more pre-dilation.However, when the stent was pulled forcefully, the shaft was separated mid shaft and remained in the guide extension catheter.A 2.0 mm non-bsc balloon was inserted into the guide extension catheter and inflated to remove the detached shaft.It was noted that the previously implanted stent was explanted and also removed.The physician thought the guide extension catheter might have damaged the implanted stent and that was why it got stuck.After confirmation under fluoroscopy and intravascular ultrasound, the decision was made to continue treatment.Stenting was done from the lesion to the site of the explanted stent to successfully complete the procedure.There was no injury to the patient.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 2.50 x 38mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.The stent was moved distally on the balloon with signs of damage along the entire length of the stent.Examination of the hypotube shaft identified multiple hypotube kinks.Examination of the outer and inner lumen and mid-shaft section found a break in the polymer extrusion at the site of the guidewire port exchange.The polymer extrusion was also stretched distal to the port exchange and therefore the guidewire the device was returned on, could not be removed.Stent struts stretched and bunched from mid-section and pulled over balloon cone and tip of device, stent outer diameter (od) could not be measured.The stent od at the time of manufacturing was within maximum crimped stent profile measurement.No other device issues were identified during returned product analysis.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18061584
• MDR Text Key: 327238931
• Report Number: 2124215-2023-57502
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Lot Number: 0029219462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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): Required Intervention