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

Catalog Number	1125350-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
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 stent dislodgement was able to be confirmed.The reported shaft kink was unable to be confirmed.The reported difficulty to position was unable to be replicated in a testing environment due to the condition of the returned device.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 reported difficulty to position was a result of the stent delivery system (sds) not being coaxially aligned, such that as the sds was being advanced it interacted with the guiding catheter and/or the other guide wires causing resistance.Interaction and/or manipulation of the device resulted in the noted stent damages (crushed, kinked) and ultimately resulted in the reported dislodged stent.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 left anterior descending (lad) coronary artery.A 3.50 x 28 mm xience alpine stent delivery system (sds) was selected for the procedure.Three guide wires were inserted through a non-abbott 7.5f sheathless radial guiding catheter; one into the lad, one into the ramus and one into the circumflex.The sds was inserted into the guiding catheter met resistance with the guiding catheter and would not pass through.A kink was noticed in the sds shaft near the site of entry.An x-ray was taken; the stent implant was not on the balloon and was found in the proximal end of the non-abbott sheathless radial guiding catheter at the point of insertion.An unspecified balloon catheter was used to capture the stent implant and remove it from the non-abbott sheathless radial guiding catheter.A new unspecified guiding catheter was put in and the procedure was successfully completed using another unspecified sds.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: 6366762
• Report Number: 2024168-2017-01651
• Device Sequence Number: 694451
• Product Code: NIQ
• UDI-Device Identifier: 08717648199554
• UDI-Public: (01)08717648199554(17)191017(10)6100741
• 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): 02/28/2017

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: 10/17/2019
• Device Catalogue Number: 1125350-28
• Device Lot Number: 6100741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• 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 CATHETER: 7.5F ASAHI SHEATHLESS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 71