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

Model Number H7493941838300

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 01/31/2021

Event Type  Injury  

Event Description

It was reported that balloon deflation failure and removal difficulty occurred.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.After the stent was deployed, the stent delivery system (sds) balloon would not fully deflate and became stuck in the implanted stent.The inflation device was replaced with a 20cc syringe and all the contrast mix was removed.The balloon was still stuck so another small balloon was placed just proximal to the stent and inflated at the same time the sds balloon was being inflated which resulted in the sds balloon being freed from the stent.Both the sds and the additional balloon were removed.A stent was placed proximal to the previously implanted synergy stent to complete the procedure.There were no patient complications reported.

Event Description

It was reported that balloon deflation failure and removal difficulty occurred.A 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.After the stent was deployed, the stent delivery system (sds) balloon would not fully deflate and became stuck in the implanted stent.The inflation device was replaced with a 20cc syringe and all the contrast mix was removed.The balloon was still stuck so another small balloon was placed just proximal to the stent and inflated at the same time the sds balloon was being inflated which resulted in the sds balloon being freed from the stent.Both the sds and the additional balloon were removed.A stent was placed proximal to the previously implanted synergy stent to complete the procedure.There were no patient complications reported.It was further reported via medwatch (b)(4) that the 3.00 x 38mm synergy xd stent was deployed at 12 atmospheres.The stent balloon was stuck in the distal third of the stent and multiple unsuccessful attempts were made to remove the balloon.

Manufacturer Narrative

B3: date of event corrected.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11352790
• MDR Text Key: 232820772
• Report Number: 2134265-2021-01448
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: H7493941838300
• Device Lot Number: 0026046362
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 77