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

Lot Number 0025620260

Device Problem Material Rupture (1546)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Event Description

It was reported that balloon rupture occurred.A 3.00 x 48mm synergy xd mr drug-eluting stent was advanced for treatment.However, during the inflation, reverse blood was confirmed in the indeflator and the balloon was suspected to be ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.

Event Description

It was reported that balloon rupture occurred.A 3.00 x 48mm synergy xd mr drug-eluting stent was advanced for treatment.However, during the inflation, reverse blood was confirmed in the indeflator and the balloon was suspected to be ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

E1- initial reporter address 1: (b)(6).Device evaluated by mfr: synergy xd mr ous 3.00 x 48mm stent delivery system (sds) was returned for analysis with the customer's 6f guide extension and nipro indeflator.A visual examination of the stent found no issues.There was no sign 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 and the result within maximum 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 tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.The wire-port was damaged.There was a blood like substance visible inside the inflation lumen.The balloon was inflated to approximately 12 atm when a leak was noted at the wire-port.The inflation fluid did not reach the balloon.The inflation device was verified before and after use using druck pressure gauge g19252.A recommended 0.014" guidewire was introduced into the device to facilitate the functional testing.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
• MDR Report Key: 12243436
• MDR Text Key: 264063415
• Report Number: 2134265-2021-09756
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Lot Number: 0025620260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1