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Model Number UNK758
Device Problems Occlusion Within Device (1423); Device Damaged by Another Device (2915); Activation Failure (3270)
Patient Problems Intimal Dissection (1333); Chest Pain (1776); Reocclusion (1985); ST Segment Depression (2487)
Event Type  Injury  
Manufacturer Narrative
Kim, j. -w. , lee, y. -h. , park, j. -h. , and lee, j. -h. (2018). Difficult stentablation with an episode of stuck and entrapped burr within the underexpanded stent. International heart journal, 413-415. (b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.   (b)(4).
Event Description
Same case as: mdr id 2134265-2018-04961 and mdr id 2134265-2018-04962. It was reported via journal article that the previously placed stent was underexpanded and restenosed. The patient later experienced non-st elevation myocardial infarction (nstemi) and a dissection. The journal article by jin-woo kim, you-hong lee, jae-hyeong park, and jae-hwan lee (2018) reported a patient case related to stentablation by rotational atherectomy. The patient presented with chest pain and was diagnosed with non-st elevation myocardial infarction (nstemi). Electrocardiogram (ecg) revealed st-segment depression in the v3-6 leads. The patient had been treated 3 times prior with percutaneous coronary interventions (pci) due to a severely underexpanded promus premier¿ stent. The stent had been deployed at a heavily calcified lesion after conventional balloon angioplasty at the time of first pci. The stent was located in the left anterior descending coronary (lad) artery that had not been corrected with standard balloon techniques. A coronary angiogram revealed total occlusion within the prior underexpanded stent at the mid-lad (thromolysis in myocardial infarction (timi) flo 0). After balloon dilatation, timi grade 3 flow was restored. However, the attending physician did not fully dilate the underexpanded stent despite multiple balloon inflations with an unspecified non-compliant balloon (2. 5 x 12 mm), which was inflated up to 24 atmospheres. After conservative treatment for 5 days, rotational atherectomy (ra) was used to ablate the unexpanded stent and the underlying calcified plaque with on-site surgical backup. Ra was attempted because the patient refused coronary artery bypass graft surgery. A non-bsc guide catheter was engaged into the left main coronary artery through the right radial artery. A bsc ivus catheter failed to pass the lesion. After introduction of an unspecified conventional 0. 014" guidewire to the distal portion of the lad using the support with a non-bsc microcatheter, a bsc 0. 009" rotawire was introduced. Ra was performed with a 1. 25 mm rotalink¿ plus burr. There was resistance while introducing the burr at the narrowest area of the stent, and the burr was suddenly stuck with an abnormal rotational sound. The rotational speed was decelerated to less than 80,000 rpm, and additional high and low speed rotational attempts failed. The operator carefully tried to withdraw the burr to prevent the breakdown of the burr head while preventing passive engagement of the guiding catheter into the proximal lad. Then, the burr was suddenly withdrawn into the guiding catheter. The operator repeatedly performed atherectomy despite entrapment of the burr. After several attempts, the burr was not stuck anymore and passed easily through the lesion without resistance. A 1. 5 mm sized burr was used instead of the 1. 25 mm burr to gain a larger luminal area. However, the burr became stuck once again and manual withdrawal was repeatedly attempted. Because the withdrawal of the 1. 5 mm burr was more difficult, the guiding catheter damaged the proximal stent strut due to deep passive engagement of the guide catheter. After several attempts, the 1. 5 mm burr passed through the lesion without resistance or speed drop. A subsequent angiogram revealed slow coronary flow to the lad with partial longitudinal stent compression at the proximal edge and focal distal stent edge dissection. Ivus demonstrated that the narrowest part of the underexpanded stent after ra was 1. 4 x 1. 5 mm diameter. The operator could obtain acceptable expansion of the stent using a bsc nc emerge 2. 5 x 8. 0 mm non-compliant balloon. Then a 2. 5 x 38 mm long bsc synergy stent was placed through the prior underexpanded stent to cover an area extending from the damaged proximal portion to the distal dissected area. Additional high-pressure balloon dilatation was performed with an unspecified 2. 5 x 8 mm balloon at 20 atm. Kissing balloon dilation was performed with an unspecified 2. 5 x 8 mm balloon for the lad and an unspecified 2. 0 x 15 balloon for the diagonal artery. A final angiography showed a fully expanded stent without residual narrowing, and the region of interest after additional balloon angioplasty on ivus was 2. 1 x 2. 2 mm. On the following day, the st-segment depression of the ecg was normalized and there was no elevation of cardiac biomarkers. No further patient complications were reported.
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Manufacturer (Section D)
Manufacturer (Section G)
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
MDR Report Key7574200
MDR Text Key110249021
Report Number2134265-2018-04918
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2018 Patient Sequence Number: 1