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

Model Number 10618

Device Problems Defective Device (2588); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Activation Failure (3270)

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

Event Date 10/19/2021

Event Type  Injury  

Event Description

It was reported that stent under expansion and damage occurred.The target lesion was located in the left anterior descending artery.After pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black colored structure present in the middle of the stent delivery system.It was felt that there was an under expansion in the mid portion of the deployed stent, so that segment was post-dilated.It was then noted there was stent malformation and elongation with the length observed as 20mm instead of 16mm as per the labeling.A long des of another company was deployed to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Correction: e1: initial reporter first name corrected from h to vs.

Event Description

It was reported that stent damage and stent under expansion occurred.The target lesion was located in the left anterior descending artery.After a 6f guiding catheter was inserted and pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black structure present in the middle of the stent delivery system.As he felt that there was an under expansion in the mid portion of the deployed stent, he post-dilated the segment and noticed that there was a malformation and stent elongation occurred and the length was observed to be 20mm instead of 16mm of its labeled length.A long des of another company was deployed to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Updated the following fields: d4.Lot number, d4.Expiration date, d4.Unique identifier (udi) #, and h4: device manufacture date.

Event Description

It was reported that stent damage and stent under expansion occurred.The target lesion was located in the left anterior descending artery.After a 6f guiding catheter was inserted and pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black structure present in the middle of the stent delivery system.As he felt that there was an under expansion in the mid portion of the deployed stent, he post-dilated the segment and noticed that there was a malformation and stent elongation occurred and the length was observed to be 20mm instead of 16mm of its labeled length.A long des of another company was deployed to complete the procedure.No patient complications were reported.

• 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: 12752831
• MDR Text Key: 280175366
• Report Number: 2134265-2021-13551
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0027434088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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