MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1804300-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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.It is possible that the stent was not fully apposed to the vessel wall resulting in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility recoil cannot be determined.The treatment appears to be related to the operational context of the procedure as post-dilatation was performed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported the procedure was to treat a heavily calcified, heavily tortuous right coronary artery (rca).Atherectomy and pre-dilatation were performed.One skypoint stent was implanted in the distal rca, a 3.0x23mm skypoint stent was deployed in the mid rca and another skypoint stent was implanted in the proximal rca.After the 3.0x23 mm skypoint stent was deployed in the mid rca, the stent was observed to recoil, even after post dilatation at a higher pressure.Waist was noted and it was not seen during post dilatation but was seen after.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded the following: this was a case to treat a 69 year old female patient, whose past medical history was unreported, for coronary artery disease of a reportedly heavily calcified and tortuous right coronary artery (rca).After the rca was prepared with atherectomy and balloon pre-dilatation, the patient had a total of three (3) xience skypoint stents deployed within the rca.The mid-rca stent reportedly recoiled after deployment and after post-dilatation attempts.Stent recoil is rare but does occur, mainly due to the thin stent struts that make up the xience skypoint drug eluting stent (des).A 2014 study showed that cobalt chromium (cocr) des have a greater susceptibility to acute recoil due to their thin stent struts, which do result in better flexibility and deliverability but at the loss of radial force that the stent can withstand.Amemiya et al found that thin stent strut metals are more flexible than the older des with thicker stent strut metal, making the thinner stents more likely to be affected by the elasticity of vessel walls and increasing the likelihood of acute recoil.Ohya et al found that a lesion with calcified plaque was a predictor of stent recoil.Several studies have found that in heavily calcified arteries, a des with thicker stent struts should be considered as they can withstand the compression or elongation forces from a heavily calcified lesion.One study found that by inflating the stent delivery balloon three (3) times instead of one (1), reduced the acute stent recoil rate.Another study suggested that a 60 second delivery balloon inflation time could result in more optimal stent expansion compared to a ten (10) second inflation time.However, such a long inflation time has the potential to chest pain and st elevation changes on the ecg.Calcified lesions are much stiffer more and non-compliant than a non-calcified lesion, making the normal eccentric vessel wall more malleable but could then recoil after stent deployment.A heavily calcified artery could force a stent to expand elliptically, making the circumference of the stent recoil elliptically.Furthermore, studies have found that using ivus or oct imaging to assist in pre and post pci, in conjunction with rotational atherectomy and a high pressure non-compliant balloon pre-dilatation, can ascertain the degree and morphology of calcification and the apposition of a stent within the calcified lesion.Additionally, amemiya et al found that if an artery was not treated optimally (acute stent under-expansion), chronic stent recoil could impact long-term outcomes, but that it is also possible that under-expanded stents will not recoil as much because they were not stretched as much acutely.Without the procedural images to review and the lack of procedural information, it cannot be stated if any procedural errors were made or what the morphology of the rca was pre and post stent deployment.It can be definitively stated that recoil of this 3.0mm x 23mm xience skypoint des, was most likely caused by the combination of a heavily calcified artery and the use of a stent with thin metal stent struts.H10: the medical review was inadvertently left out of the final mdr; therefore, this report is being filed to submit the medical review.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13560839
• MDR Text Key: 285833366
• Report Number: 2024168-2022-01718
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 1091641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2 XIENCE SKYPOINT STENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female