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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as the correct date was not provided.
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 3.50x24mm synergy drug-eluting stent, it was noted that the stent was wrinkled after pulling off the protective cover.The patient was not harmed as the device did not enter the patient's body.
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as the correct date was not provided.Device evaluated by mfr.: synergy ii us mr 3.50 x 24mm stent delivery system was returned for analysis.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 crimped 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 tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found multiple shaft kinks at several locations along the shaft polymer extrusion.Severe stretching of the outer shaft polymer extrusion was evident from 137.5cm distal to the distal strain relief as far as 155.5cm distal to the distal strain relief.Wire lumen separation was noted at a location 137.5cm distal to the distal strain relief, with no wire lumen evident inside the stretched outer, as far as 155.5cm distal to the distal strain relief.Wire lumen bunching was evident at a location 156cm distal to the distal strain relief.A visual and microscopic examination of the bumper tip showed no signs of damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 3.50x24mm synergy drug-eluting stent, it was noted that the stent was wrinkled after pulling off the protective cover.The patient was not harmed as the device did not enter the patient's body.

• 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: 8589198
• Report Number: 2134265-2019-04905
• Device Sequence Number: 19249088
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/02/2019

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: 11/05/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022939388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1