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

Catalog Number	1125400-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
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.Evaluation summary: only the stent was returned for analysis; therefore the reported stent dislodgement was confirmed.The reported difficult to position was unable to be replicated in a testing environment as the sds was not returned.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported difficulty to position was a result of the sds not being coaxially aligned, such that as the sds was being advanced it interacted with the guide extension catheter causing resistance.Interaction with the guide extension catheter and/or manipulation of the device resulted in the noted stent damages (mangled, flared) and ultimately resulted in the reported stent dislodgement.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.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 procedure was to treat a lesion in the non-tortuous, heavily calcified proximal left anterior descending (lad) coronary artery.A 4.00 x 18 mm xience alpine stent delivery system (sds) was selected for the procedure.During advancement of the sds to the lesion the sds met resistance with the non-abbott guide extension catheter (gec), the stent implant dislodged from the balloon and remained inside the gec.The sds and the gec were removed from the anatomy as one unit and the stent implant was retrieved from inside the gec.The procedure was completed with the successful deployment of a 4.00 x 15 mm xience alpine stent implant.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 6545475
• Report Number: 2024168-2017-03924
• Device Sequence Number: 1391492
• Product Code: NIQ
• UDI-Device Identifier: 08717648199622
• UDI-Public: (01)08717648199622(17)200212(10)7020641
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/04/2017

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: 02/12/2020
• Device Catalogue Number: 1125400-18
• Device Lot Number: 7020641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATH EXTENSION: GUIDEZILLA
• Patient Age: 60 YR
• Patient Weight: 98