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

Catalog Number	1125350-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
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.The device was not returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.The 3.0 x 12 and 3.5 x 12 nc travelers referenced in describe event or problem are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, eccentric, and heavily calcified de novo second diagonal branch artery that was 99% stenosed.A 3.0 x 12 mm nc traveler was used to pre-dilate the lesion, but resistance was met with the lesion during advancement, and the balloon catheter ruptured at 14 atmospheres (atm) during the second inflation.Pre-dilation was therefore done with a non-abbott balloon catheter.Then there was an attempt to deploy a 3.5 x 12 xience alpine stent, but the stent did not expand enough due to the heavy calcification of the lesion.Therefore, post-dilation was attempted with a 3.5 x 12 mm nc traveler.However, resistance was met with the lesion during advancement, and the balloon catheter ruptured at 18 atm during the first inflation.The stent delivery system was then used for post-dilation followed by further post-dilation with a non-abbott balloon catheter.The xience alpine stent was successfully implanted though it was deformed due to the heavy calcification of the lesion.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Required intervention to prevent permanent impairment/damage(devices) was removed.(b)(4).

• 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: 6591845
• Report Number: 2024168-2017-04502
• Device Sequence Number: 1278810
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: (01)08717648199516(17)171222(10)4121061
• 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,Followup
• Report Date (Section B): 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2017
• Device Catalogue Number: 1125350-12
• Device Lot Number: 4121061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention