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

Model Number	10607
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the right coronary artery.A 3.50 x 38 mm synergy drug-eluting stent was implanted for treatment.However, during removal, the balloon was stuck inside the stent.The balloon was eventually removed completing the procedure.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the right coronary artery.A 3.50 x 38mm synergy drug-eluting stent was implanted for treatment.However, during removal, the balloon was stuck inside the stent.The balloon was eventually removed completing the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.50 x 38 mm stent delivery system was returned for analysis without a stent.The stent was not returned for analysis as it was successfully implanted.The balloon cones were reviewed, and no visible defects were noted.There was evidence that positive and negative pressure had been applied as the balloon was returned in a deflated state.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the polymer extrusion shaft.The balloon was inflated to rated burst pressure without issue.The device was deflated successfully within deflation time specification.The inflation device was verified before and after.A recommended 0.014 inch guidewire was introduced into the device to facilitate the functional testing.No other issues were identified during the product analysis.

• 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: 8759172
• Report Number: 2134265-2019-07063
• Device Sequence Number: 16516310
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 08/01/2019

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: 02/03/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023329375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR