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

Lot Number 0026065890

Device Problem Material Rupture (1546)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 4.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during inflation before reaching at 9 atmospheres at approximately 10 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 4.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during inflation before reaching at 9 atmospheres at approximately 10 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the balloon was damage during the first inflation and there were any difficulties noted during advancing over the wire and through the guide catheter.

Manufacturer Narrative

E1: initial reporter city: (b)(6).

• 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: 12763123
• MDR Text Key: 280691580
• Report Number: 2134265-2021-13993
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Lot Number: 0026065890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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