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

Model Number	10603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 2.50 x 20mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent was not adhered to the balloon properly.The procedure was completed with a new synergy stent.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 2.50 x 20mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent was not adhered to the balloon properly.The procedure was completed with a new synergy stent.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 2.50 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged from mid-section of the stent to the end of the stent with stent struts pulled and stretched distally over the tip.The undamaged stent outer diameter was measured and the result is 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 damage.A visual and tactile examination of the hypotube multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues with the extrusion shaft.No other issues were identified during the product analysis.It was reported that this synergy stent moved on balloon during the procedure.The complaint report stated that the stent moved on balloon but during analysis it was noted that the stent was firmly crimped on balloon and stent struts had stretched on the distal section of the stent.Stent movement on balloon cannot be confirmed.Taking into consideration the evaluation and the details of the complaint, this investigation is assigned the most probable root cause classification of no problem detected.A complaint with a most probable root cause of no problem detected indicates that the device complaint or problem cannot be confirmed.Procedural factors most likely contributed to the stent damage that was noted during analysis.The complaint report did not highlight any shaft kinks occurring during the procedure, it is most likely that the hypotube kinks that were noted during analysis occurred due to handling post procedure.

• 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: 8361647
• Report Number: 2134265-2019-01510
• Device Sequence Number: 1959306
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/10/2019

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: 04/16/2019
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 22033854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR