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

Model Number H7493941848400

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

Event Description

It was reported that the stent was not visible under fluoroscopy.A 4.00 x 48m synergy xd drug-eluting stent was advanced and deployed into the lesion.However, during inflation of the balloon, the stent was unable to be visualized under x-ray.After deflation of the balloon, the stent was also unable to be visualized under x-ray.The patient was checked again; however, the stent was still unable to be visualized under x-ray.No patient complications were reported.

Event Description

It was reported that the stent was not visible under fluoroscopy.A 4.00 x 48m synergy xd drug-eluting stent was advanced and deployed into the lesion.However, during inflation of the balloon, the stent was unable to be visualized under x-ray.After deflation of the balloon, the stent was also unable to be visualized under x-ray.The patient was checked again; however, the stent was still unable to be visualized under x-ray.No patient complications were reported.

Manufacturer Narrative

B3 date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.Device evaluated by mfr.: synergy xd mr us 4.00 x 48mm stent delivery system was returned for analysis.The device was returned with no stent attached.The crimped stent outer diameter measured during manufacture was within maximum crimped stent profile measurement.The balloon returned in a deflated state.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found 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: 12939542
• MDR Text Key: 281862588
• Report Number: 2134265-2021-15414
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: H7493941848400
• Device Lot Number: 0026341268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• 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