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

Model Number	10603
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.A synergy ii us mr 4.00 x 20mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The device was returned with the mandrel partially inserted and the stent protector placed on the mandrel but not covering the stent.The mandrel could not be removed due to the condition of the returned device.The mandrel outer diameter was measured and was within specification.The outer shaft polymer extrusion was damaged with 3.8cm of stretching, kinks and twisting at a location 138.2cm-142cm distal to the distal strain relief.The device was returned with the mandrel inserted as far as the outer shaft polymer extrusion damage.There was an inner shaft polymer extrusion break located 138.2cm distal to the distal strain relief (proximal break site), with a distal inner shaft polymer extrusion break site located 143.1cm distal to the distal strain relief.Multiple shaft polymer extrusion kinks were also identified.The balloon was 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 tactile examination of the hypotube found no issues.An examination (visual and via scope) found no issues with the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 18oct2019.It was reported that stylet removal difficulty was encountered and catheter damage occurred.During preparation of a 4.00 x 20 synergy drug-eluting stent, the stylet could not be removed from the device and the catheter was ruined.The device was never used inside the patient.However, returned device analysis revealed inner shaft polymer extrusion break.

• 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: 9293639
• Report Number: 2134265-2019-13345
• Device Sequence Number: 11288696
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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 Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023392642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1