MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10622
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.00 x 32mm synergy ii drug-eluting stent was advanced for treatment.However, the stent came off the balloon.The dislodged device was snared from the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.00 x 32mm synergy ii drug-eluting stent was advanced for treatment.However, the stent came off the balloon.The dislodged device was snared from the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii des stent delivery system (sds) was returned for analysis without the stent, the hypotube shaft and the manifold hub and on a guide wire and inside a guidecatheter.The fgb, upn and size provided by the customer for this device cannot be confirmed due to the missing manifold hub which contains the catheter lot and serial number as well as the product name and size.An emerge 3.00x15mm device was also noted to be inside the same guidecatheter but on a different wire.The device was returned without a stent.A manufacturing crimps stent data was performed and since the sds was not returned with the stent all 300 results recorded during crimping of this fgb were reviewed.All devices passed the crimping measurement test with results within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as its wings were relaxed and not tightly folded.Red/brown blood like substance noted inside/outside the balloon cones.A visual and microscopic examination of the bumper tip showed no signs of tip damage.No inspection of this region was performed as it was not returned with the device.A visual and tactile examination of the outer and mid-shaft section found a break in the shaft polymer extrusion measured at 29 cm proximal to the distal end of the tip.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10225463
• Report Number: 2134265-2020-08301
• Device Sequence Number: 10899692
• Product Code: NIQ
• UDI-Device Identifier: 08714729973478
• UDI-Public: 08714729973478
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 08/24/2020

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: 07/21/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024183139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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