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

Model Number 10619

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Initial rporter facility name: (b)(6).

Event Description

It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.00 x 20 synergy drug-eluting stent was advanced for treatment.However, during procedure, the device was wound with a non-boston scientific guidewire, could not reach the lesion, and was stuck.The stent and the guidewire were removed as usual but very carefully and slowly.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

Event Description

It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.00 x 20 synergy drug-eluting stent was advanced for treatment.However, during procedure, the device was wound with a non-boston scientific guidewire, could not reach the lesion, and was stuck.The stent and the guidewire were removed as usual but very carefully and slowly.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

E1- initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: synergy ous mr 4.00 x 20 mm stent delivery system was returned for analysis.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 markerbands.The crimped stent outer diameter was measured and the result was 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 microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.Device was loaded successfully onto a 0.0140 inch test guidewire.No issues were identified during the product analysis.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15028652
• MDR Text Key: 296046853
• Report Number: 2124215-2022-25612
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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,Followup
• Report Date: 09/22/2022

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: 07/21/2023
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0027773944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 71 KG