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

Catalog Number	1125325-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
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: the device was returned for analysis.The reported difficulty to remove 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 sds met resistance during removal over the guide wire due to a buildup/coagulation of procedural contaminants (blood, contrast) thus causing the sds to become stuck on the guide wire.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 an eccentric de novo lesion in the non-tortuous, heavily calcified, 75% stenosed, proximal right coronary artery (rca).A 3.25 x 12 mm xience alpine stent delivery system (sds) was selected for the procedure.The sds was advanced with no resistance to the lesion and the stent was successfully implanted.To ensure that the stent was fully apposed to the artery wall the sds balloon was inflated to 10 atmospheres three times.During removal of sds from the anatomy, resistance was felt with the non-abbott guide wire.In order to facilitate the removal of the sds, the guide wire was pushed and pulled until the sds was independently removed from the anatomy.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: 6364868
• Report Number: 2024168-2017-01616
• Device Sequence Number: 943471
• Product Code: NIQ
• UDI-Device Identifier: 08717648199424
• UDI-Public: (01)08717648199424(17)191024(10)6101741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 10/24/2019
• Device Catalogue Number: 1125325-12
• Device Lot Number: 6101741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/28/2017
• 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 WIRE: SION BLUE