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

Catalog Number	1125350-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported defective item/incorrect size was unable 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 the physician inadvertently selected the 3.5 x 23 mm xience alpine in which the length of the stent was shorter or longer compared to the lesion that was needed to be covered by the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.The nc trek referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right coronary artery that did not have any tortuosity.A 3.5 x 23 mm xience alpine stent was used; however, it was noted under fluoroscopy that the stent was the incorrect size.Therefore, another unspecified stent was implanted in the lesion.Then, a 3.5 x 12 mm nc trek balloon catheter was used for post-dilatation; however, the balloon ruptured below the rated burst pressure.Therefore, another 3.5 x 12 mm nc trek balloon catheter was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7122017
• Report Number: 2024168-2017-09786
• Device Sequence Number: 11241821
• Product Code: NIQ
• UDI-Device Identifier: 08717648199547
• UDI-Public: 08717648199547
• 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): 12/15/2017

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: 09/07/2020
• Device Catalogue Number: 1125350-23
• Device Lot Number: 7082461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1