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

Model Number	H7493952838400
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that balloon deflation failed and catheter entrapment occurred.The target lesion was located in the right coronary artery (rca).After crossing the lesion with a non-bsc guide wire, a 4.00 x 38 mm promus premier¿ drug eluting stent was deployed.However upon balloon deflation, the balloon failed to collapse properly and the catheter was hung up on the guide wire.The entire system was removed and a new guide wire and a balloon catheter were used to complete the procedure.No patient complications were reported and the patient¿s status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent was not returned for analysis.It was deployed inside the patient¿s body as per complaint report.The sds was returned inserted inside a guide catheter.The balloon cones were reviewed and no issues were noted.Balloon wings were relaxed from their original folded position appearing as if positive pressure was applied.As part of the analysis, inflation of the device was attempted.The returned device was attached to an encore inflation device and positive pressure was applied in an attempt to inflate the balloon.The balloon inflated without any issues noted and deflated within 7 seconds which is within specification.A visual examination of the tip showed signs of damages at the distal edges of the tip.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system of the device.A visual and tactile examination of the outer and mid-shaft section found no issues with the 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 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 failed and catheter entrapment occurred.The target lesion was located in the right coronary artery (rca).After crossing the lesion with a non-bsc guide wire, a 4.00x38mm promus premier¿ drug eluting stent was deployed.However upon balloon deflation, the balloon failed to collapse properly and the catheter was hung up on the guide wire.The entire system was removed and a new guide wire and a balloon catheter were used to complete the procedure.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: 6540483
• Report Number: 2134265-2017-04389
• Device Sequence Number: 734568
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: (01)08714729845041(17)20170906(10)19066419
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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: 09/06/2017
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 19066419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/22/2017
• 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: Other
• Patient Age: 78 YR