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

Model Number 10621

Device Problem Material Rupture (1546)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured occurred.A 3.00 x 28mm synergy ii drug eluting stents was selected for use in the percutaneous coronary intervention (pci) procedure.The target lesion was none tortuous and none calcified lesion.The synergy stent was unable to deploy, when the physician removed the device from patient body the balloon had a hole at the proximal end and the balloon leak at 4 atmospheres.The procedure was completed successfully with another of the synergy stent device was used.There was no patient compilations reported.

Event Description

It was reported that the balloon ruptured occurred.A 3.00 x 28mm synergy ii drug eluting stents was selected for use in the percutaneous coronary intervention (pci) procedure.The target lesion was none tortuous and none calcified lesion.The synergy stent was unable to deploy, when the physician removed the device from patient body the balloon had a hole at the proximal end and the balloon leak at 4 atmospheres.The procedure was completed successfully with another of the synergy stent device was used.There was no patient compilations reported.

Event Description

It was reported that the balloon ruptured occurred.A 3.00 x 28mm synergy ii drug eluting stents was selected for use in the percutaneous coronary intervention (pci) procedure.The target lesion was none tortuous and none calcified lesion.The synergy stent was unable to deploy, when the physician removed the device from patient body the balloon had a hole at the proximal end and the balloon leak at 4 atmospheres.The procedure was completed successfully with another of the synergy stent device was used.There was no patient compilations reported.

Manufacturer Narrative

Device evaluated by manufacturer: the returned product consisted of a 3.00 x 28mm synergy stent delivery system (sds).Visual examination of the stent found signs of stent damage.Stent struts in the proximal section of the stent was found to be flared and distal stent struts were found to be lifted from their crimped position.The undamaged stent od (outer diameter) was measured using snap gauge and the result was within maximum crimped stent profile measurement.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located in the proximal balloon cone at 3.7 cm proximal to the distal tip.The rated burst pressure of this synergy device is 16 atm.Inflation device was verified before and after use using a druck pressure gauge.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified no issues with the hypotube of this device.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: SYNERGY
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13508245
• MDR Text Key: 285620953
• Report Number: 2134265-2022-01385
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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: 08/19/2023
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0027981129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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