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

Model Number	10603
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in mildy tortuous and severely calcified distal left main artery into the circumflex artery.Pre-dilation was performed with a 3.5 x 15 apex balloon catheter following a 3.50 x 20 synergy ii drug eluting coronary stent advanced for treatment.However, during post-dilatation with 3.5 x 12 nc quantum apex the stent was fractured near the bifurcation of left main and circumflex carina.They placed the second synergy stent 3.5x8 inside to cover the fractured part.The fractured device was not removed but the balloon was removed over the wire in the normal fashion and no issues reported.The procedure was completed with different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Boston scientific medical personnel media review: a review of the media provided could not identify the alleged stent fracture, however, a gap which could indicate strut displacement was noted in the proximal to mid stent region.The apparent strut displacement noted could have appeared to the physician as stent fracture, however, this was not the case as 2 connectors are noted midway on the gap opening.Additionally, the displaced struts visible in the photo review most likely represent a conformation of the stent [allowed by the 4-connector proximal (first 2 rows) and 2 connector throughout and in the distal section design as per synergy everolimus-eluting platinum design documentation], to the vessel anatomy by considering the presence of fibro-calcific lesions and provide the required scaffolding without any straightening of the vessel.Additionally, the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors almost on the same plane on view (very close together), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.H3 other text : media review.
Event or Problem Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in mildly tortuous and severely calcified distal left main artery into the circumflex artery.Pre-dilation was performed with a 3.5 x 15 apex balloon catheter following a 3.50 x 20 synergy ii drug eluting coronary stent advanced for treatment.However, during post-dilatation with 3.5 x 12 nc quantum apex the stent was fractured near the bifurcation of left main and circumflex carina.They placed the second synergy stent 3.5x8 inside to cover the fractured part.The fractured device was not removed but the balloon was removed over the wire in the normal fashion and no issues reported.The procedure was completed with different device.There were no patient complications reported and the patient status was stable.

• 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: 11947779
• Report Number: 2134265-2021-07330
• Device Sequence Number: 16432361
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: 08714729840183
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0026322270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention