MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493952824300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.00x24mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent came off the balloon.A balloon catheter was then advanced into the stent and the stent was deployed where it was and the procedure was ended.Later that evening, the patient was brought back to the cath lab and another stent was implanted in the initially intended location and the procedure was completed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: fg, promus premier, us, mr 3.00x24mm stent delivery system (sds) was returned for analysis without a stent.No stent returned.Stent separated from sds.The balloon was reviewed.There was no stent on the balloon.The balloon folds were present but were not tightly wrapped; it did not appear that the balloon had been subjected to positive pressure.Crimp markings were evident on the balloon indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found a mid-shaft kink 100mm proximal to port bond.A visual and microscopic examination found no damage to the tip.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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.00x24mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent came off the balloon.A balloon catheter was then advanced into the stent and the stent was deployed where it was and the procedure was ended.Later that evening, the patient was brought back to the cath lab and another stent was implanted in the initially intended location and the procedure was completed.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6457345
• Report Number: 2134265-2017-03450
• Device Sequence Number: 563318
• Product Code: NIQ
• UDI-Device Identifier: 08714729844853
• UDI-Public: (01)08714729844853(17)20180521(10)20015280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

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: 05/21/2018
• Device Model Number: H7493952824300
• Device Catalogue Number: 39528-2430
• Device Lot Number: 20015280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/08/2017
• 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