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

Model Number H7493941848300

Device Problem Break (1069)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and mildly calcified vessel.A 3.00 x 48mm synergy xd drug-eluting stent was advanced to treat the lesion.However, when introducing the stent into the body, the tech pulled negative and blood entered the inflation device.Subsequently, the device was removed and it was noted that the mid shaft was fractured and came out in two pieces.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

The synergy xd mr us 3.50 x 38mm stent delivery system (sds) was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 38.3cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break occurred.The target lesion was located in mildly tortuous and mildly calcified vessel.A 3.00 x 48mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noted that the tech did pulled negative and blood entered the inflation device.During the removal, the mid shaft was fractured and came out in two pieces.The procedure was completed with a new stent.No patient complications were reported.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14148982
• MDR Text Key: 289666118
• Report Number: 2134265-2022-04271
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: 08714729985228
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: H7493941848300
• Device Lot Number: 0028082104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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