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

Model Number 10632

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.(b)(6).

Event Description

It was reported that stent premature deployment occurred.During preparation of a 3.00 x 48 mm synergy drug-eluting stent, it was noted that the stent deployed by itself.The procedure was completed with a different device and no patient complications were reported.

Event Description

It was reported that stent premature deployment occurred.During preparation of a 3.00 x 48mm synergy drug-eluting stent, it was noted that the stent deployed by itself.The procedure was completed with a different device and no patient complications were reported.

Manufacturer Narrative

Device is a combination product.B3 - date of event: used the first date of the month of the aware date as no event date was provided.E1: initial reporter cityb: (b)(6).Device evaluated by mfr.: synergy ous mr 3.00 x 48 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts starting from the mid stent region all the way to the distal end of the stent were lifted from their crimped position and pulled distally over the distal balloon cone and tip.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was 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 damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other 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
• MDR Report Key: 8823609
• MDR Text Key: 152104323
• Report Number: 2134265-2019-08569
• 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: 09/16/2019

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: 11/02/2020
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0023780232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1