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

Model Number	10620
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in a large saphenous vein graft.A non-bsc guide wire and 6fr guide catheter were placed, and a 5.0x24mm synergy drug eluting stent was deployed.When the stent delivery system (sds) was being removed, the sds got stuck on the guidewire in the guide catheter and the soft part of the balloon started to stretch.The devices were all removed together.The guide catheter was reinserted and another guidewire placed.The stent was post dilated with a 5.0x14mm apex balloon.Everything looked good and the patient did great.
Additional Manufacturer Narrative
Device is combination product.Device evaluated by mfr.: synergy ii us mr 5.00 x 24mm stent delivery system was returned for analysis.The returned device was attached to a filter-wire.The filter-wire was removed distally without issue.No stent was returned with the device.The balloon cones showed signs of being subjected to positive pressure, and the balloon was in a deflated state.A visual and microscopic examination of the bumper tip showed distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found port bond site damage, with a tear along the length of the port bond site.The outer clear polymer extrusion was stretched and torn at several locations along the shaft.The inner black polymer extrusion was stretched and torn at several locations along the shaft.A shaft break, with the corewire exposed, was noted 133.4cm distal to the distal strain relief.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in a large saphenous vein graft.A non-bsc guide wire and 6fr guide catheter were placed, and a 5.0x24mm synergy drug eluting stent was deployed.When the stent delivery system (sds) was being removed, the sds got stuck on the guidewire in the guide catheter and the soft part of the balloon started to stretch.The devices were all removed together.The guide catheter was reinserted and another guidewire placed.The stent was post dilated with a 5.0x14mm apex balloon.Everything looked good and the patient did great.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9359219
• Report Number: 2134265-2019-14290
• Device Sequence Number: 2220106
• Product Code: NIQ
• UDI-Device Identifier: 08714729973454
• UDI-Public: 08714729973454
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0022909315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1