MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926012400
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The in-stent restenosed previous non-bsc stent was located in the proximal to mid left anterior descending (lad) artery.A 4.0 x 38 stent was deployed in the mid to distal portion of the previous stent and then overlapped it with a 4.00 x 12 synergy ii in the proximal portion.However, upon removal of the stent delivery system, the catheter became stuck on the wire.Both devices were removed together.The 4.00 x 12 synergy ii stent was successfully implanted and the procedure was completed.No patient complications were reported and the patient was doing well.
Event or Problem Description
It was reported that catheter entrapment occurred.The in-stent restenosed previous non-bsc stent was located in the proximal to mid left anterior descending (lad) artery.A 4.0 x 38 stent was deployed in the mid to distal portion of the previous stent and then overlapped it with a 4.00 x 12 synergy ii in the proximal portion.However, upon removal of the stent delivery system, the catheter became stuck on the wire.Both devices were removed together.The 4.00 x 12 synergy ii stent was successfully implanted and the procedure was completed.No patient complications were reported and the patient was doing well.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: the synergy ii us, mr, 4.00 x 12 mm stent delivery system was returned for analysis.The stent was not returned for analysis.As per complaint report the stent was successfully deployed at the targeted lesion.The crimped stent od (outer diameter) at the time of manufacturing was within maximum crimped stent profile measurement.The balloon folds appeared relaxed indicating that the balloon may have been inflated and deflated.Bunching was noted at the proximal end of the balloon.Further analysis was performed , the balloon was inflated using an inflation device and there were no leaks noted verifying that the balloon was not damaged.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage most likely occurred due to excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.The device was returned with a guide-wire loaded in the wire lumen with 28mm of guide-wire protruding from the device tip.The od of the returned guidewire was measured.The protruding section of the guide-wire was the 'floppy' soft end of the wire and it had a u-shape.The wire was withdrawn from the device and slight resistance was met.The same wire was re-loaded into the device via the tip, tracked through the device and withdrawn from the device and only met resistance when withdrawing the floppy u-shaped end of the wire from the device, however the guide-wire could be removed.An examination of the floppy end of the wire identified traces of a substance, consistent with blood, on the surface of the floppy section of wire.It is likely that this contributed to the minor resistance.A recommended 0.014'' guide-wire was then loaded into the device via the tip, tracked through the device, withdrawn from the device with no issues or resistances were noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The in-stent restenosed previous non-bsc stent was located in the proximal to mid left anterior descending (lad) artery.A 4.0 x 38 stent was deployed in the mid to distal portion of the previous stent and then overlapped it with a 4.00 x 12 synergy ii in the proximal portion.However, upon removal of the stent delivery system, the catheter became stuck on the wire.Both devices were removed together.The 4.00 x 12 synergy ii stent was successfully implanted and the procedure was completed.No patient complications were reported and the patient was doing well.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: the synergy ii us, mr, 4.00 x 12 mm stent delivery system was returned for analysis.The stent was not returned for analysis.As per complaint report the stent was successfully deployed at the targeted lesion.The crimped stent od (outer diameter) at the time of manufacturing was within maximum crimped stent profile measurement.The balloon folds appeared relaxed indicating that the balloon may have been inflated and deflated.Bunching was noted at the proximal end of the balloon.Further analysis was performed , the balloon was inflated using an inflation device and there were no leaks noted verifying that the balloon was not damaged.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage most likely occurred due to excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.The device was returned with a guide-wire loaded in the wire lumen with 28mm of guide-wire protruding from the device tip.The od of the returned guidewire was measured.The protruding section of the guide-wire was the 'floppy' soft end of the wire and it had a u-shape.The wire was withdrawn from the device and slight resistance was met.The same wire was re-loaded into the device via the tip, tracked through the device and withdrawn from the device and only met resistance when withdrawing the floppy u-shaped end of the wire from the device, however the guide-wire could be removed.An examination of the floppy end of the wire identified traces of a substance, consistent with blood, on the surface of the floppy section of wire.It is likely that this contributed to the minor resistance.A recommended 0.014'' guide-wire was then loaded into the device via the tip, tracked through the device, withdrawn from the device with no issues or resistances were noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7643865
• Report Number: 2134265-2018-05625
• Device Sequence Number: 2413093
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 03/20/2019
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 0021920501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1