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

Model Number	H7493952816350
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that balloon deflation slow occurred.The target lesion was located in the left circumflex artery (lcx).A 3.50x16mm promus premier drug eluting stent (des) was advanced to treat the lesion.The stent delivery system was inflated with a 50% saline and 50% contrast solution to a total of 12ml.However upon the first and second inflations, the balloon failed to expand.On the third attempt, the balloon was able to be inflated and the stent was successfully deployed.Post implantation, it was noticed that the balloon was slow to deflate.Using the indeflator, it took for 4-5 times in applying negative pressure to completely deflate the balloon.The device was completely removed and the procedure was completed with this device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: stent delivery system (sds) was returned for analysis.The stent had detached and was not returned for analysis.The balloon body was reviewed and the balloon appeared to have been inflated and subsequently subjected to negative pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of hardened medium inside balloon body along extrusion.The device was soaked in water-bath at a temperature of 37 degrees for 48 hours to help soften the hardened medium before further inflation attempts were made.The device was removed from the water-bath and the balloon was again attached to an inflation device and positive pressure was applied.The balloon was inflated to rated burst pressure (rbp) with no restrictions noted.No balloon leak or balloon break was noted.No leaks were noted in any part of the delivery catheter.The balloon was deflated within 6 seconds with no issues.The deflation time was within specification.The bumper tip of the device showed no signs of damage.A visual and tactile examination found multiple kinks on the hypotube shaft.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 their profile.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that balloon deflation slow occurred.The target lesion was located in the left circumflex artery (lcx).A 3.50 x 16 mm promus premier¿ drug eluting stent (des) was advanced to treat the lesion.The stent delivery system was inflated with a 50% saline and 50% contrast solution to a total of 12 ml.However upon the first and second inflations, the balloon failed to expand.On the third attempt, the balloon was able to be inflated and the stent was successfully deployed.Post implantation, it was noticed that the balloon was slow to deflate.Using the indeflator, it took for 4-5 times in applying negative pressure to completely deflate the balloon.The device was completely removed and the procedure was completed with this device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6309406
• Report Number: 2134265-2017-00627
• Device Sequence Number: 1159612
• Product Code: NIQ
• UDI-Device Identifier: 08714729844747
• UDI-Public: (01)08714729844747(17)20180114(10)0019511269
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/17/2017

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: 01/14/2018
• Device Model Number: H7493952816350
• Device Catalogue Number: 39528-1635
• Device Lot Number: 0019511269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1