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

Lot Number 0031548209

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.Following rotablation, the vessel remained highly tortuous and after multiple attempts to advance the stent, it still failed to successfully position.Consequently, the decision was made to remove the stent from the vessel uninflated.However, while removing, it was noticed that the stent mesh was dislodged.The detached component did not travel and was successfully retrieved with the help of guidezilla guide extension catheter.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.Following rotablation, the vessel remained highly tortuous and after multiple attempts to advance the stent, it still failed to successfully position.Consequently, the decision was made to remove the stent from the vessel uninflated.However, while removing, it was noticed that the stent mesh was dislodged.The detached component did not travel and was successfully retrieved with the help of guidezilla guide extension catheter.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

A stent belonging to a synergy xd mr ous 2.25 x 24mm stent delivery system was returned for analysis.Visual, tactile, and microscopic analysis revealed the stent was damaged along multiple points with stretching and bunching visible along its entire length.The stent outer diameter at the time of manufacture was within specification.

• 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: 18962473
• MDR Text Key: 338390540
• Report Number: 2124215-2024-17067
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031548209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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