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

Catalog Number	1125250-38
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The chipboard box and the foil pouch were returned for analysis.The reported device marking issue was able to be confirmed.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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a mix-up occurred at the hospital.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 when opening a chipboard box labeled as a 2.5x38mm size, lot number 6091941,rx xience alpine drug-eluting stent (des) system, it was discovered that the inner foil pouch was labeled as a 2.5x28mm size with lot number 6090641.The inner foil pouch remained sealed and was not opened.The site had confirmed that the outer chipboard box was sealed prior to opening.There was no patient involvement and this issue did not cause or contribute to a clinically significant delay.Another 2.5x38mm rx xience alpine des was opened and used without issue.No additional information was 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: 6476603
• Report Number: 2024168-2017-02971
• Device Sequence Number: 16479885
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219(17)190926(10)6091941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/10/2017

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: 09/28/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6091941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1