MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement outside the patient occurred.The target lesion was located in a coronary artery.A 3.00 x 24 synergy drug-eluting stent delivery system (sds) was advanced to the lesion when it was noted that the stent was on the catheter just outside the tuohy.The stent never entered the patient.The sds balloon was used to pre-dilate the lesion and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.A synergy was returned for analysis with the stent detached.The stent was not returned for analysis.The maximum stent outer diameter measured at time of manufacture was within maximum crimped stent profile measurement.The balloon was reviewed.The balloon was in a deflated state with evidence of crimp marks and signs that positive pressure had been applied.No other issues were noted with the balloon.A visual and microscopic examination of the bumper tip found evidence of tip damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The guidewire exchange port was damaged and twisted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement outside the patient occurred.The target lesion was located in a coronary artery.A 3.00 x 24 synergy drug-eluting stent delivery system (sds) was advanced to the lesion when it was noted that the stent was on the catheter just outside the touhy.The stent never entered the patient.The sds balloon was used to pre-dilate the lesion and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9391922
• Report Number: 2134265-2019-14458
• Device Sequence Number: 13884414
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024187151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR