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

Model Number 10621

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that catheter entrapment occurred.A 3.00 x 28 synergy drug-eluting stent was selected for use.However, when placing the device on the wire, severe resistance was felt and could not advanced the stent.The device was stuck and unable to be removed from the wire.Eventually, the device was successfully removed and the procedure was completed with another of same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 3.00x28 stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts at the proximal end of the stent lifted and flared.Proximal end of stent covering proximal marker band with no excessive stent stretching noted.The undamaged 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 signs of tip damage.A visual and tactile examination of the hypotube found a kink 20mm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a kink 190mm proximal of the distal tip as well as inner lumen bunching 30mm proximal to the distal end of the distal tip.A 0.014'' guidewire was loaded through distal tip but could not track through as there was an obstruction 30mm from the distal tip.No other issues were identified during the product analysis.

Event Description

It was reported that catheter entrapment occurred.A 3.00 x 28 synergy drug-eluting stent was selected for use.However, when placing the device on the wire, severe resistance was felt and could not advanced the stent.The device was stuck and unable to be removed from the wire.Eventually, the device was successfully removed and the procedure was completed with another of same device.There were no patient complications nor injuries 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: 10459489
• MDR Text Key: 204539347
• Report Number: 2134265-2020-10869
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0024846369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1