MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926008400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The 60% stenosed target lesion was located in the non-tortuous and moderate to severely calcified left main artery.A 4.00 x 8 synergy ii drug-eluting stent was advanced to treat the lesion.However, upon inflating the stent balloon, the stent slid back off the balloon onto the balloon shaft.The physician did not notice until the device was removed out of the patient's body that the stent was on the balloon shaft.A 4.0 x 8 promus premier drug-eluting stent was then advanced and was successfully deployed in the left main and the procedure was completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) 20451524-112 was returned for analysis.A visual examination found that the stent appeared expanded and detached from the balloon.The stent had moved in a proximal direction over the proximal end of the polymer extrusion.Distal stent row 1 appeared damaged with a stent strut lifted and pulled distally.The maximum crimped stent profile measurement at the time of manufacture was within specification.The balloon cones were reviewed and no issues were noted.The balloon cones appear relaxed from their original folded position and appear to have been subjected to positive pressure.Hardened medium was evident inside the balloon body.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 the full length of the catheter.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found a shaft polymer extrusion kink 5 mm proximal to the bi-component bond.No other issues were identified during the product analysis.A review of the manufacturing data for the stent profile was carried out and no anomalies were noted.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The 60% stenosed target lesion was located in the non-tortuous and moderate to severely calcified left main artery.A 4.00 x 8 synergy ii drug-eluting stent was advanced to treat the lesion.However, upon inflating the stent balloon, the stent slid back off the balloon onto the balloon shaft.The physician did not notice until the device was removed out of the patient's body that the stent was on the balloon shaft.A 4.0 x 8 promus premier drug-eluting stent was then advanced and was successfully deployed in the left main and the procedure was completed.No patient complications were reported and the patient's status was fine.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6890750
• Report Number: 2134265-2017-09480
• Device Sequence Number: 633579
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: 08714729840015
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: 03/23/2018
• Device Model Number: H7493926008400
• Device Catalogue Number: 39260-0840
• Device Lot Number: 0020456304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1