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

Model Number H7493941832300

Device Problems Material Rupture (1546); Defective Device (2588); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Pain (1994); Vasoconstriction (2126); Discomfort (2330)

Event Date 03/02/2022

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred and the patient experienced vasospasms and pain.The 80% stenosed target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery.A 3.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.The stent was delivered in the normal manner with no issues.When the physician started to dial pressure on the indeflator and got to 11-12 atmospheres, no contrast could be seen on fluoroscopy.The physician pulled negative and tried to re-inflate but was unsuccessful and it was noticed that there was blood in the indeflator.It was unknown if the balloon had ruptured or if there was a hole in the shaft.The device was pulled back out of the coronary artery and halfway into another manufacturers 6fr ebu 3.75 guide catheter.Afterwards the guide catheter, guidewire and the stent were pulled back into the radial artery.However, the stent came off the balloon and had to be snared and removed from the radial artery through the radial sheath.At this time that patient experienced radial artery vascospasms and pain in their right arm.The physician was unable to completely retrieve the device.The stent became foreshortened and compressed into a small ball of metal.Everything was removed from the patients right radial artery.A transradial band was applied and hemostasis was achieved.The patient experienced considerable pain and discomfort upon removal of the device from the radial artery.A follow-up angiogram was done from the right subclavian artery all the way down to the wrist to make sure there was no perforation or dissections present.The procedure was completed with a 3.00mm x 38mm synergy xd drug-eluting stent.No further patient complications were reported and the patient has fully recovered.

Event Description

It was reported that stent dislodgement occurred and the patient experienced vasospasms and pain.The 80% stenosed target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery.A 3.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.The stent was delivered in the normal manner with no issues.When the physician started to dial pressure on the indeflator and got to 11-12 atmospheres, no contrast could be seen on fluoroscopy.The physician pulled negative and tried to re-inflate but was unsuccessful and it was noticed that there was blood in the indeflator.It was unknown if the balloon had ruptured or if there was a hole in the shaft.The device was pulled back out of the coronary artery and halfway into another manufacturers 6fr ebu 3.75 guide catheter.Afterwards the guide catheter, guidewire and the stent were pulled back into the radial artery.However, the stent came off the balloon and had to be snared and removed from the radial artery through the radial sheath.At this time that patient experienced radial artery vasospasms and pain in their right arm.The physician was unable to completely retrieve the device.The stent became foreshortened and compressed into a small ball of metal.Everything was removed from the patients right radial artery.A transradial band was applied and hemostasis was achieved.The patient experienced considerable pain and discomfort upon removal of the device from the radial artery.A follow-up angiogram was done from the right subclavian artery all the way down to the wrist to make sure there was no perforation or dissections present.The procedure was completed with a 3.00mm x 38mm synergy xd drug-eluting stent.No further patient complications were reported and the patient has fully recovered.It was further reported that the target lesion was 90% stenosed, moderately tortuous and moderately calcified with mild angulation.Pre-dilation was done with emerge balloon catheter.Multiple inflations were attempted after ends of stent were flared out.During inflation, the device hold very little pressure.There were no issues on the packaging nor significant resistance at any stage.The opacification of balloon never occurred during inflation as well.

• 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: 13802944
• MDR Text Key: 288092741
• Report Number: 2134265-2022-02665
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0028036541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White