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

Model Number	H7493952816250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Stent delivery system (sds) was returned for analysis.The stent detached from the delivery system and was not returned for analysis.The bumper tip of the device showed no signs of damage.The balloon body was reviewed and the balloon folds appeared disturbed.Solidified media was evident inside balloon chamber.A visual and tactile examination found that the hypotube had broken 219mm distal from distal edge of strain relief and multiple kinks on the hypotube shaft were noted.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.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
Reportable based on device analysis completed on (b)(6) 2016.It was reported that crossing difficulties were encountered.The target lesion was located in the left anterior descending (lad) artery.A 2.50x16mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.No patient complications were reported.However, returned device analysis revealed stent detachment and hypotube break.It was further reported that during the procedure, the stent dislodged in the right coronary artery and was subsequently snared out of the patient's body.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6265021
• Report Number: 2134265-2016-12673
• Device Sequence Number: 13665395
• Product Code: NIQ
• UDI-Device Identifier: 08714729844716
• UDI-Public: (01)08714729844716(17)20170817(10)18967970
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• 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
• Report Date (Section B): 12/27/2016

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: 08/17/2017
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 18967970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/19/2017
• 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