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

Model Number	10604
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that device contamination occurred.A 3.00x24mm synergy stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that device contamination occurred.A 3.00x24mm synergy stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.:synergy ii us mr 3.00 x 24 mm stent delivery system was returned for analysis in a biohazard bag, without product mandrel & stent protector and with the proximal region of the hypotube shaft including the manifold missing.A visual examination of the stent found signs of stent damage.Stent struts in mid to distal stent region were noted to be lifted and pulled over the distal balloon cone.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were 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 signs of damage on the distal end of the bumper tip.A visual and tactile examination of the hypotube shaft found the shaft broken at 50.4 cm proximal to the distal end of the tip as well as a shaft kink situated at 47.2 cm proximal to the distal end of the tip.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.D10: returned to manufacturer date corrected from 22nov2019 to 05dec2019.

• 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: 9395344
• Report Number: 2134265-2019-14229
• Device Sequence Number: 18927853
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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 Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023943021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1