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

Model Number	10603
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 75% stenosed target lesion was located in a mildly tortuous and mildly calcified coronary artery.A 4.00 x 20 synergy drug-eluting stent was selected for use.However, the stent was stuck when it was being loaded onto a non-boston scientific guide wire.Both devices were removed together from the guide catheter.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluation by mfr.: synergy ii us mr 4.00 x 20 stent delivery system was returned for analysis.There was no guidewire/guide catheter returned with device.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The 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 no signs of tip damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A 0.014" guidewire loaded through distal tip and exited port bond without issue.No issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.The 75% stenosed target lesion was located in a mildly tortuous and mildly calcified coronary artery.A 4.00 x 20 synergy drug-eluting stent was selected for use.However, the stent was stuck when it was being loaded onto a non-boston scientific guide wire.Both devices were removed together from the guide catheter.The procedure was completed with another of the same device.No patient complications nor injuries were 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: 10749851
• Report Number: 2134265-2020-14586
• Device Sequence Number: 14218270
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/08/2020

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: 01/19/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0025088777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1