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

Model Number	H7493952812220
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device was not received for 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 inadequate apposition, shaft break, balloon removal difficulty and vessel occlusion occurred.The target lesion was located in the right coronary artery.A 2.25x12mm promus premier¿ drug-eluting stent was advanced through the non-bsc guide extension catheter and stent was then deployed at 16 atmospheres.The balloon deflated but there was a waist in the middle of the stent after the physician attempted to retrieve the delivery catheter.The delivery catheter separated and the balloon was trapped inside the stent.The balloon occluded the vessel.The physician then attempted to snare the balloon out but was unsuccessful.Subsequently, the patient underwent for an emergent open heart surgery.The portion of the catheter that remained inside the patient was surgically retrieved.No further patient complications were reported.
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
It was reported that stent inadequate apposition, shaft break, balloon removal difficulty and vessel occlusion occurred.The target lesion was located in the right coronary artery.A 2.25x12mm promus premier drug-eluting stent was advanced through the non-bsc guide extension catheter and stent was then deployed at 16 atmospheres.The balloon deflated but there was a waist in the middle of the stent after the physician attempted to retrieve the delivery catheter.The delivery catheter separated and the balloon was trapped inside the stent.The balloon occluded the vessel.The physician then attempted to snare the balloon out but was unsuccessful.Subsequently, the patient underwent for an emergent open heart surgery.The portion of the catheter that remained inside the patient was surgically retrieved.No further patient complications were reported.
Additional Manufacturer Narrative
The device was not returned for analysis however, two obtained images of the device post procedure shows what appears to be the separation location.(b)(4).
Event or Problem Description
It was reported that stent inadequate apposition, shaft break, balloon removal difficulty and vessel occlusion occurred.The target lesion was located in the right coronary artery.A 2.25x12mm promus premier drug-eluting stent was advanced through the non-bsc guide extension catheter and stent was then deployed at 16 atmospheres.The balloon deflated but there was a waist in the middle of the stent after the physician attempted to retrieve the delivery catheter.The delivery catheter separated and the balloon was trapped inside the stent.The balloon occluded the vessel.The physician then attempted to snare the balloon out but was unsuccessful.Subsequently, the patient underwent for an emergent open heart surgery.The portion of the catheter that remained inside the patient was surgically retrieved.No further patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6601023
• Report Number: 2134265-2017-05100
• Device Sequence Number: 19049299
• Product Code: NIQ
• UDI-Device Identifier: 08714729844648
• UDI-Public: (01)08714729844648(17)20180705(10)20169600
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/05/2017

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: 07/05/2018
• Device Model Number: H7493952812220
• Device Catalogue Number: 39528-1222
• Device Lot Number: 20169600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 01/24/2018; 03/01/2018
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 02/16/2018; 03/14/2018
• 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
• Patient Age: 67 YR