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

Model Number 10623

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.

Event Description

It was reported that removal difficulties were encountered and stent fracture occurred.The target lesion was located in a coronary artery.The 2.50 x 38mm synergy drug-eluting stent was selected for treatment.However, upon advancing through the guide catheter, the stent got stuck with the balloon that was already inserted.It was noted that the stent itself was broken.The device was removed together with the system and the procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr.: synergy ous mr 2.50 x 38mm stent delivery system was returned for analysis with two 0.014 guide wires in carrier hoops.A 6f terumo guide catheter and a 2.00 x 15mm sapphire balloon also returned within a carrier hoop.An examination (visual and via scope) of the crimped stent found stent damage.The stent was damaged with struts on the distal end bunched proximally, and first proximal strut row slightly flared.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and the proximal balloon wings was relaxed.It was evident that the balloon had been subjected to positive and negative pressure.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of shaft polymer extrusion profile identified no issues.No other issues were identified during the product analysis.

Event Description

It was reported that removal difficulties were encountered and stent fracture occurred.The target lesion was located in a coronary artery.The 2.50 x 38mm synergy drug-eluting stent was selected for treatment.However, upon advancing through the guide catheter, the stent got stuck with the balloon that was already inserted.It was noted that the stent itself was broken.The device was removed together with the system and the procedure was completed with another of the same device.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
• MDR Report Key: 8791387
• MDR Text Key: 151119959
• Report Number: 2134265-2019-07937
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0022835202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1