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

Model Number 10619

Device Problem Premature Activation (1484)

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

Event Date 08/21/2022

Event Type  malfunction  

Event Description

It was reported that stent premature deployment occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left main to left anterior descending artery.A 4.00 x 20 synergy drug-eluting stent was advanced to treat the lesion.However, the stent got inflated while advancing through the guide catheter.The device was removed and the procedure was completed with other stent.There were no patient complications reported.

Manufacturer Narrative

Initial reporter address 1:(b)(6).

Event Description

It was reported that stent premature deployment occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left main to left anterior descending artery.A 4.00 x 20 synergy drug-eluting stent was advanced to treat the lesion.However, the stent got inflated while advancing through the guide catheter.The device was removed and the procedure was completed with other stent.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter address (b)(6).Device evaluated by mfr: synergy ous mr 4.00 x 20mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified that the stent struts were damaged.Stent struts at the proximal end of the stent were flared.The mid and distal section of stent had its stent struts stretched distally along distal balloon cone.The balloon cones were reviewed, and it was noted that there were traces of solidified media in the proximal balloon cone.A visual and microscopic examination of the bumper tip identified no tip damage.A visual and tactile examination of the hypotube shaft found no kinks.No kinks or damages were identified along the entire length of the distal extrusion.

• 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: 15349260
• MDR Text Key: 303251963
• Report Number: 2124215-2022-32444
• 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
• Report Date: 12/13/2022

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: 06/29/2023
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0027647368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Race: Asian