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

Model Number	H7493952820350
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break and stent damage occurred.The target lesion was located in a vessel in the left lower extremity.A 3.50x20mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, upon advancing, the physician thought that the stent came off the balloon and decided to pull the device back.Upon pulling the device, the catheter shaft broke in half and the stent balloon portion of the catheter remained in the patient's body.Subsequently, the remaining portion of the catheter was removed with a snare and after removal, the stent was noted to have accordioned onto itself.The device was completely removed from the patient's body.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was returned for analysis.The proximal part of the stent delivery system (sds) with manifold/hub was not returned for analysis therefore the batch/serial number could not be identified.A visual examination of the stent found that the stent was damaged at the proximal end of the stent and pushed over the proximal markerband.Stent struts at the proximal end were squashed and pushed proximally.There is slight proximal stent movement on the balloon at the proximal end of the stent.The undamaged mid-section of the crimped stent od (outer diameter) was measured and is within the maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure; however a slight damage to the proximal balloon cone was noted.A visual and tactile examination found that the hypotube shaft was broken and not returned for analysis.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 that the proximal part of the shaft polymer extrusion had broken 245mm proximal to the bumper tip.The bi-component bond showed no signs of damage or strain.This type of damage is consistent with excessive force being applied to the delivery system.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 shaft break and stent damage occurred.The target lesion was located in a vessel in the left lower extremity.A 3.50x20mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, upon advancing, the physician thought that the stent came off the balloon and decided to pull the device back.Upon pulling the device, the catheter shaft broke in half and the stent balloon portion of the catheter remained in the patient's body.Subsequently, the remaining portion of the catheter was removed with a snare and after removal, the stent was noted to have accordioned onto itself.The device was completely removed from the patient's body.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: 6278707
• Report Number: 2134265-2017-00136
• Device Sequence Number: 358221
• Product Code: NIQ
• UDI-Device Identifier: 08714729844808
• UDI-Public: (01)08714729844808(17)20171005(10)0019160507
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/03/2017

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: 10/05/2017
• Device Model Number: H7493952820350
• Device Catalogue Number: 39528-2035
• Device Lot Number: 0019160507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 02/21/2017
• 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