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

Model Number	10607
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month ((b)(6) 2020) of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent damage occurred.A 4.00 x 38 synergy drug-eluting stent was selected for use.However, during guide catheter insertion, the stent was damaged.There were no known patient complications reported.
Event or Problem Description
It was reported that stent damage occurred.A 4.00 x 38 synergy drug-eluting stent was selected for use.However, during guide catheter insertion, the stent was damaged.There were no known patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.B3 - date of event: used the first date of the month (01jun2020) of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 4.00 x 38mm stent delivery system catheter was returned for analysis.A visual examination of the stent found the stent damaged with stent strut rows from the proximal to mid stent region lifted and bunched distally in the middle region of the stent.The undamaged stent outer diameter was measured within maximum crimped stent profile measurement.The balloon body was exposed in the proximal to middle balloon region with crimp markings visible on the balloon body.The balloon cones were reviewed no issues were noted.The balloon wings were tightly wrapped and folded and were not subjected to positive pressure.A visual examination of the bumper tip found no issues.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.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: 10190063
• Report Number: 2134265-2020-08475
• Device Sequence Number: 3017030
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 07/02/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024073085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1