MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125300-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Prepared in the anatomy and negative pulled during device preparation.Evaluation summary: the device was returned for analysis.Visual and functional inspections were performed on the returned device.The leak was not confirmed.The stent delivery system (sds) was pressurized to the minimum rated burst pressure (rbp) of 18 atm, and the sds held pressure without any leaks noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) instructs the user to flush the device prior to entering the anatomy.Additionally, the ifu instructs: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.This may cause dislodgement of the stent from the balloon.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the 3.0x38mm xience alpine stent delivery system (sds) was prepared inside the patients anatomy.While pulling negative, blood was noted coming back.A leak was suspected.The device was removed and a non-abbott sds was used in replacement.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5907091
• Report Number: 2024168-2016-05727
• Device Sequence Number: 18950756
• Product Code: NIQ
• UDI-Device Identifier: 08717648199394
• UDI-Public: (01)08717648199394(17)190126(10)6011941
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2016

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: 01/26/2019
• Device Catalogue Number: 1125300-38
• Device Lot Number: 6011941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1