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

Catalog Number	1125300-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was a clinically significant delay in the procedure, but there was no adverse patient sequela reported.No additional information was provided.Medical devices: guide wire: joker, bmw elite ii, stent: xience alpine 3.25 x 23mm.Evaluation summary: the device was returned for analysis.The reported kinked and stretched inner member were confirmed.The reported deflation issues were not confirmed due the condition the device was returned.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 similar incidents from this lot.The investigation was not able to determine a conclusive cause for the reported inner member damage (kinked and stretched).Additionally, the reported deflation issue appears to be related to the operational context of the procedure.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 de novo lesion in a moderately tortuous mid left anterior descending artery (lad) that was 90% stenosed.An unspecified guide wire crossed the lesion and an optical frequency domain imaging (ofdi) was performed.Pre-dilatation was then done with a 3.0 x 15 mm traveler balloon dilatation catheter at 8 atmospheres (atms) three times.A 3.0 x 28 mm xience alpine stent was implanted in the lesion and was dilated three times at 10 atms, 12 atms and 12 atms, and then a 3.25 x 23 mm xience alpine stent was deployed proximally to the implanted stent (overlapping it) at 10 atms four times.Another ofdi was performed and it was determined that further post-dilatation was needed for the 3.0 x 28 mm xience alpine stent.Therefore, the stent delivery balloon of the 3.0 x 28 mm xience alpine stent was reinserted to post dilate it at 18 atms.However, the balloon would not deflate; therefore, negative pressure was applied several times with an inflation device to inflate the balloon but it was still not possible to deflate it.Then, an unspecified guide wire and an unspecified microcatheter were advanced in order to rupture the balloon; however, this attempt also failed.After 9 minutes, it was then noted under cine that the balloon gradually deflated on its own.Therefore, the stent delivery system was removed from the anatomy, the stent remained implanted in the lesion and no further treatment was performed at that time.It was noted that the inner member inside the balloon was stretched and kinked.There was no issue in inflating and deflating the balloon outside the anatomy.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the reported deflation issues were not confirmed as functional testing met specification.

• 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: 7509002
• Report Number: 2024168-2018-03517
• Device Sequence Number: 217400
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• 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: 2018
• 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): 06/21/2018

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: 07/01/2018
• Device Catalogue Number: 1125300-28
• Device Lot Number: 5062641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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