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

Device Problem Obstruction of Flow (2423)

Patient Problem Restenosis (4576)

Event Date 10/13/2022

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The patient presented with restenosis and underwent percutaneous coronary intervention.The target lesion was located in the severely tortuous mid right coronary artery.A non-boston scientific (bsc) scoring balloon was used followed by using a non-bsc guide extension catheter to place a non-bsc stent on a restenosed synergy stent implanted about 3 to 4 years ago.A 3.50mm x 15mm nc emerge balloon catheter was advanced for post-dilatation.The balloon was inflated two times at 22 atmospheres and 28 atmospheres for 30 seconds with 1:1 saline ratio.However, during the second inflation, the balloon ruptured at 25 atmospheres and the balloon could not deflate.The device was recovered by utilizing a non-bsc guide extension catheter and pulling it out.No patient complications were reported.

Manufacturer Narrative

Implant date: used the first date of the year 2019 as the device was implanted about 3-4 years ago.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15695074
• MDR Text Key: 302678927
• Report Number: 2124215-2022-42871
• 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
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: GUIDE EXTENSION CATHETER: GUIDE PLUS; SCORING BALLOON: NSE ALPHA
• Patient Outcome(s): Other; Required Intervention