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

Model Number	10603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.In (b)(6) 2019, the patient underwent left heart catheterization to treat an occluded stent in the diagonal artery.Following pre-dilatation with a 2.5mm balloon, a 2.50 x 20 synergy drug-eluting stent was advanced.The stent was unable to be deployed and during removal, the device broke.Fourteen days later, a diagnostic heart catheterization was performed and a synergy drug-eluting stent was observed in the left anterior descending artery (lad).An occlusion was noted distal to the stent.The occlusion looked to be a balloon (2 markers) that was left in the proximal lad.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was not returned to the complaint investigation site (cis) for analysis.However, some images of the procedure were received with this complaint.A review of the images can confirm that a device separation occurred.The complaint information also stated that "there is an occlusion distal to the synergy stent and looks to be a balloon (2 markers) that were left in the proximal lad".A request was made to get a copy of the angio from this procedure, however it was confirmed that this would not be available.It is noted that a shaft break is consistent with excessive tensile force having been applied to the shaft.Images of the procedure were received and analyzed.
Event or Problem Description
It was reported that shaft break occurred.In (b)(6) 2019, the patient underwent left heart catheterization to treat an occluded stent in the diagonal artery.Following pre-dilatation with a 2.5mm balloon, a 2.50 x 20 synergy drug-eluting stent was advanced.The stent was unable to be deployed and during removal, the device broke.Fourteen days later, a diagnostic heart catheterization was performed and a synergy drug-eluting stent was observed in the left anterior descending artery (lad).An occlusion was noted distal to the stent.The occlusion looked to be a balloon (2 markers) that was left in the proximal lad.It was further reported that the synergy stent became entangled on the previous stent and after pulling on the stent system to remove it, the stent catheter broke.Snaring was attempted but failed.The patient was then referred to a cardiac surgeon in another facility.

• 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: 8984171
• Report Number: 2134265-2019-10348
• Device Sequence Number: 311804
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/08/2019

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: 04/24/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023723307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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